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Clinical Trial Results:
Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 with Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects

Summary
EudraCT number	2012-004124-38
Trial protocol	DE GB
Global end of trial date	29 Nov 2014

Results information
Results version number	v1(current)
This version publication date	29 Jul 2016
First version publication date	29 Jul 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

AI468-002

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussee de la Hulpe 185, Brussels, Belgium, 1170

Public contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

29 Nov 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

29 Nov 2014

Was the trial ended prematurely?

Main objective of the trial

Primary Objective was to assess the antiviral activity in HIV-1 infected subjects following administration of BMS-955176 for 10 days.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Apr 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

South Africa: 46

Country: Number of subjects enrolled

United Kingdom: 6

Country: Number of subjects enrolled

Germany: 139

Worldwide total number of subjects

191

EEA total number of subjects

145

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

191

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 3 centres in 3 countries.

Screening details

Out of 191 subjects enrolled only 107 subjects (Part A: 60 subjects; Part B: 28 subjects; and Part C: 19 subjects) received treatment during the study, 84 subjects had not received treatment due to various reasons as: Subject Withdrew Consent-3, Pregnancy-3, Subject No Longer Meets Study Criteria-73 and Other-5.

Period 1 title

Part A (HIV-1 Clade B)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Data analyst, Carer, Subject, Assessor

Are arms mutually exclusive

Yes

Part A-Group 1: BMS-955176 (5 mg)

Arm description

Subjects infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, once daily (QD) from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 5 mg BMS-955176 as oral suspension, QD.

Part A-Group 2: BMS-955176 (10 mg)

Arm description

Subjects infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 10 mg BMS-955176 as oral suspension, QD.

Part A-Group 3: BMS-955176 (20 mg)

Arm description

Subjects infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 20 mg BMS-955176 as oral suspension, QD.

Part A-Group 4: BMS-955176 (40 mg)

Arm description

Subjects infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 40 mg BMS-955176 as oral suspension, QD.

Part A-Group 9: BMS-955176 (80 mg)

Arm description

Subjects infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 80 mg BMS-955176 as oral suspension, QD.

Part A-Group 10: BMS-955176 (120 mg)

Arm description

Subjects infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 120 mg BMS-955176 as oral suspension, QD.

Placebo Clade B

Arm description

Subjects infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose,

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with matching placebo QD.

Number of subjects in period 1 ^[1]	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Placebo Clade B
Started	8	8	8	8	8	8	12
Completed	8	8	8	8	8	8	12

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Out of 191 subjects who were enrolled, 107 subjects were randomised and were distributed in the 3 parts of the study; Part A: 60 subjects; Part B: 28 subjects; and Part C: 19 subjects.

Period 2 title

Part B (HIV-1 Clade B)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part B-Group 5: BMS-955176 (40 mg) + Atazanavir

Arm description

Subjects infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Subjects were evaluated for a total period of 42 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 40 mg BMS-955176 as oral suspension, QD.

Investigational medicinal product name

Atazanavir

Investigational medicinal product code

Other name

Reyataz™

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 400 mg Atazanavir as capsules, QD.

Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir

Arm description

Subjects infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Subjects were evaluated for a total period of 42 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

Ritonavir

Investigational medicinal product code

Other name

Norvir™

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 100 mg Ritonavir tablet orally, QD.

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 40 mg BMS-955176 as oral suspension, QD.

Investigational medicinal product name

Atazanavir

Investigational medicinal product code

Other name

Reyataz™

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 300 mg Atazanavir as capsules, QD.

Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine

Arm description

Subjects infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Subjects were evaluated for a total period of 42 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

Tenofovir

Investigational medicinal product code

Other name

Viread™

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 300 mg Tenofovir orally, QD.

Investigational medicinal product name

Emtricitabine

Investigational medicinal product code

Other name

Emtriva™

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 200 mg Emtricitabine orally, QD.

Investigational medicinal product name

Atazanavir

Investigational medicinal product code

Other name

Reyataz™

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 300 mg Atazanavir as capsules, QD.

Investigational medicinal product name

Ritonavir

Investigational medicinal product code

Other name

Norvir™

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 100 mg Ritonavir tablet orally, QD.

Part B-Group 12: BMS-955176 (80 mg) + Atazanavir

Arm description

Subjects infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Subjects were evaluated for a total period of 42 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 80 mg BMS-955176 as oral suspension, QD.

Investigational medicinal product name

Atazanavir

Investigational medicinal product code

Other name

Reyataz™

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 400 mg Atazanavir as capsules, QD.

Number of subjects in period 2 ^[2]	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Started	8	8	4	8
Completed	8	8	4	8

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: 107 subjects were randomised and were distributed in the 3 parts of the study; Part A: 60 subjects; Part B: 28 subjects; and Part C: 19 subjects.

Period 3 title

Part C (HIV-1 Clade C only)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Part C-Group 8: BMS-955176 (40 mg)

Arm description

Subjects infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 40 mg BMS-955176 as oral suspension, QD.

Part C-Group 13: BMS-955176 (120 mg)

Arm description

Subjects infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Experimental

Investigational medicinal product name

BMS-955176

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with 120 mg BMS-955176 as oral suspension, QD.

Placebo Clade C

Arm description

Subjects infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects were treated with matching placebo QD.

Number of subjects in period 3 ^[3]	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade C
Started	8	7	4
Completed	8	7	4

Notes
[3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: A total of 107 subjects were randomised and were distributed in the 3 parts of the study; Part A: 60 subjects; Part B: 28 subjects; and Part C: 19 subjects

Baseline characteristics

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Reporting group title

Part A-Group 1: BMS-955176 (5 mg)

Reporting group description

Reporting group title

Part A-Group 2: BMS-955176 (10 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 3: BMS-955176 (20 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 4: BMS-955176 (40 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 9: BMS-955176 (80 mg)

Reporting group description

Reporting group title

Part A-Group 10: BMS-955176 (120 mg)

Reporting group description

Reporting group title

Placebo Clade B

Reporting group description

Subjects infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose,

Reporting group values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Placebo Clade B	Total
Number of subjects	8	8	8	8	8	8	12	60
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	41.6 ( 8.73 )	37.5 ( 11.07 )	33.3 ( 7.19 )	39.5 ( 8.09 )	36.3 ( 11.23 )	38 ( 9.49 )	36.3 ( 7.12 )	-
Gender categorical
Units: Subjects
Female	0	1	0	0	0	0	0	1
Male	8	7	8	8	8	8	12	59

End points

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Reporting group title

Part A-Group 1: BMS-955176 (5 mg)

Reporting group description

Reporting group title

Part A-Group 2: BMS-955176 (10 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 3: BMS-955176 (20 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 4: BMS-955176 (40 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 9: BMS-955176 (80 mg)

Reporting group description

Reporting group title

Part A-Group 10: BMS-955176 (120 mg)

Reporting group description

Reporting group title

Placebo Clade B

Reporting group description

Subjects infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose,

Reporting group title

Part B-Group 5: BMS-955176 (40 mg) + Atazanavir

Reporting group description

Reporting group title

Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir

Reporting group description

Reporting group title

Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine

Reporting group description

Reporting group title

Part B-Group 12: BMS-955176 (80 mg) + Atazanavir

Reporting group description

Reporting group title

Part C-Group 8: BMS-955176 (40 mg)

Reporting group description

Subjects infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part C-Group 13: BMS-955176 (120 mg)

Reporting group description

Subjects infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Placebo Clade C

Reporting group description

Subjects infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Primary: Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels from Baseline to Day 11

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End point title

Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels from Baseline to Day 11 ^[1]

End point description

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected subjects. Change in the plasma HIV-1 RNA levels were measured in the subjects infected with HIV-1 clade B and C who undergone BMS-955176 monotherapy. The analysis was performed in all treated subjects who had received at least one dose of study drug.

End point type

Primary

End point timeframe

Baseline and Day 11 after the final dose with BMS-955176

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: copies per millilitre (c/mL)
arithmetic mean (standard deviation)	-0.138 ( 0.1281 )	-0.567 ( 0.5845 )	-0.889 ( 0.6582 )	-1.279 ( 0.4596 )	-1.339 ( 0.29 )	-1.326 ( 0.3855 )	-1.216 ( 0.4366 )	-1.431 ( 0.2967 )	-1.544 ( 0.4155 )	-1.521 ( 0.2651 )	-1.29 ( 0.3376 )	-0.938 ( 0.6897 )	0.118 ( 0.5277 )	-0.172 ( 0.7876 )

No statistical analyses for this end point

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C

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End point title

Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C ^[2]

End point description

Time to reach the maximum plasma concentration was directly determined from concentration time data. The analysis was performed in all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Pre-dose Day 1 to Day 10

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: Hours
median (full range (min-max))
Day 1	3 (1.5 to 6)	2.51 (2 to 4)	3 (3 to 6)	4 (2 to 6)	3.5 (3 to 4)	3 (1.5 to 6)	3.5 (2 to 10)	3.53 (2 to 4.25)
Day 10	3 (2 to 4)	3 (1.5 to 4)	4 (3 to 16)	3 (2 to 6)	3 (1.5 to 4.02)	2.5 (1.5 to 3.87)	3 (2 to 6)	3 (1.55 to 4)

No statistical analyses for this end point

Secondary: Number of Subjects With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the study

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End point title

Number of Subjects With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the study

End point description

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Analysis was performed in all the randomised subjects who received at least 1 dose of double-blind study medication in the Treatment Period.

End point type

Secondary

End point timeframe

Day 1 to up to end of the study (Day 42)

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: subjects
Deaths	0	0	0	0	0	0	0	0	0	0	0	0	0	0
SAEs	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Related SAEs	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Discontinuations due to SAEs	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Discontinuations due to AEs	0	0	0	0	0	0	0	0	0	0	0	0	0	0
AEs	5	5	5	6	8	7	8	8	4	6	7	6	9	3

No statistical analyses for this end point

Secondary: Maximum Decline from Baseline in Log10 HIV-1 Ribonucleic Acid (RNA)

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End point title

Maximum Decline from Baseline in Log10 HIV-1 Ribonucleic Acid (RNA)

End point description

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected subjects. Maximum decline from baseline in the plasma HIV-1 RNA levels were measured in the subjects infected with HIV-1 clade B and C. The analysis was performed in all treated subjects who had received at least one dose of study drug.

End point type

Secondary

End point timeframe

Part A and C: Baseline up to Day 24; Part B: Baseline up to Day 42

Part A-Group 1: BMS-955176 (5 mg)

Part A-Group 2: BMS-955176 (10 mg)

Part A-Group 3: BMS-955176 (20 mg)

Part A-Group 4: BMS-955176 (40 mg)

Part A-Group 9: BMS-955176 (80 mg)

Part A-Group 10: BMS-955176 (120 mg)

Part B-Group 5: BMS-955176 (40 mg) + Atazanavir

Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir

Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine

Part B-Group 12: BMS-955176 (80 mg) + Atazanavir

Part C-Group 8: BMS-955176 (40 mg)

Part C-Group 13: BMS-955176 (120 mg)

Placebo Clade B

Placebo Clade C

Number of subjects analysed

Units: c/mL

median (full range (min-max))

-0.498 (-0.78 to -0.22)

-0.976 (-1.76 to -0.64)

-1.115 (-2.12 to -0.13)

-1.701 (-1.88 to -0.93)

-1.555 (-1.82 to -1.04)

-1.654 (-2.07 to -0.83)

-1.858 (-2.37 to -1.49)

-2.202 (-3.52 to -1.24)

-2.39 (-3.04 to -1.83)

-2.228 (-2.68 to -1.87)

-1.352 (-2.03 to -1.04)

-1.257 (-2.02 to -0.7)

-0.381 (-1.46 to 0.56)

-0.419 (-1.21 to 0.22)

No statistical analyses for this end point

Secondary: Time to Maximum Decline in Log 10 HIV-1 Ribonucleic Acid (RNA)

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End point title

Time to Maximum Decline in Log 10 HIV-1 Ribonucleic Acid (RNA)

End point description

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected subjects. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the subjects infected with HIV-1 clade B and C. The analysis was performed in all treated subjects who had received at least one dose of study drug.

End point type

Secondary

End point timeframe

Part A and C: Baseline up to Day 24; Part B: Baseline up to Day 42

Part A-Group 1: BMS-955176 (5 mg)

Part A-Group 2: BMS-955176 (10 mg)

Part A-Group 3: BMS-955176 (20 mg)

Part A-Group 4: BMS-955176 (40 mg)

Part A-Group 9: BMS-955176 (80 mg)

Part A-Group 10: BMS-955176 (120 mg)

Part B-Group 5: BMS-955176 (40 mg) + Atazanavir

Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir

Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine

Part B-Group 12: BMS-955176 (80 mg) + Atazanavir

Part C-Group 8: BMS-955176 (40 mg)

Part C-Group 13: BMS-955176 (120 mg)

Placebo Clade B

Placebo Clade C

Number of subjects analysed

Units: Hours

median (full range (min-max))

168 (72 to 433.4)

216 (48 to 553.5)

203.9 (168 to 288.1)

240.15 (120.1 to 312.1)

204 (168 to 384.6)

240.2 (216 to 288.3)

624 (360 to 816.3)

636.05 (216 to 816.9)

588 (528 to 672.1)

636.05 (528 to 816.3)

228.05 (192 to 384.6)

215.8 (120 to 312)

216.2 (24 to 433.8)

132.05 (23.9 to 786.3)

No statistical analyses for this end point

Secondary: Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts

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End point title

Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts

End point description

Change in the CD4+ and CD8+ cell counts from baseline were measured in the subjects infected with HIV-1 clade B and C who undergone BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. The analysis was performed in all treated subjects who had received at least one dose of study drug. Here 'n' signifies number of subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Part A and C: Baseline up to Day 24; Part B: Baseline up to Day 42

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: Cells/microlitre
arithmetic mean (standard deviation)
CD4+ (n = 6,7,7,7,8,7,5,7,4,4,6,6,9,4)	-21.8 ( 88.37 )	14.6 ( 120.82 )	-70.1 ( 68.49 )	-23.6 ( 42.13 )	-43.8 ( 69.5 )	-56.7 ( 78.26 )	-133.2 ( 84.14 )	-106.4 ( 166.59 )	33 ( 144.79 )	-89 ( 35.71 )	-53.7 ( 93.76 )	24.5 ( 57.58 )	-77.3 ( 91.05 )	18 ( 67.3 )
CD8+ (n = 6,7,7,7,8,7,5,7,4,4,6,6,9,4)	-95 ( 301.52 )	-8.3 ( 236.48 )	-107.4 ( 264.26 )	-57.3 ( 126.25 )	-194.6 ( 182.3 )	-161.3 ( 203.01 )	-442.8 ( 243.99 )	-466.1 ( 491.21 )	-216.3 ( 287.06 )	-147 ( 140.67 )	-214.4 ( 390.13 )	-155.8 ( 56.55 )	-93.1 ( 138.52 )	-136.3 ( 224.49 )

No statistical analyses for this end point

Secondary: Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent

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End point title

Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent

End point description

Percent Change in the CD4+ and CD8+ cell counts from baseline were measured in the subjects infected with HIV-1 clade B and C who undergone BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. The analysis was performed in all treated subjects who had received at least one dose of study drug. Here 'n' signifies number of subjects evaluable for this endpoint at specified time points.

End point type

Secondary

End point timeframe

Part A and C: Baseline up to Day 24; Part B: Baseline up to Day 42

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: Percent change
arithmetic mean (standard deviation)
CD4+ (n = 6,7,7,7,8,7,5,8,4,4,6,6,9,4)	2.33 ( 2.944 )	0.29 ( 2.215 )	-1.29 ( 5.057 )	0.86 ( 3.288 )	2.13 ( 3.399 )	0.29 ( 2.87 )	2.4 ( 2.881 )	3.25 ( 3.105 )	4.75 ( 2.217 )	-0.75 ( 1.893 )	0.5 ( 3.017 )	3.17 ( 3.371 )	-0.22 ( 3.93 )	2.75 ( 3.775 )
CD8+ (n = 6,7,7,7,8,7,5,8,4,4,6,6,9,4)	1.17 ( 2.401 )	0.43 ( 3.207 )	0 ( 6.325 )	1 ( 3.225 )	-0.25 ( 5.064 )	-2.29 ( 2.812 )	-2.8 ( 1.924 )	-6.25 ( 4.464 )	-3.75 ( 2.062 )	-1.25 ( 2.217 )	0 ( 1.871 )	-4.25 ( 3.775 )	1.75 ( 4.2 )	-1.33 ( 5.132 )

No statistical analyses for this end point

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) - Part B

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End point title

Time to Reach Maximum Plasma Concentration (Tmax) - Part B

End point description

Tmax was directly determined from concentration time data. The analysis was performed in all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Pre-dose Day 1 to Day 28

End point values	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Number of subjects analysed	8	8	8
Units: Hours
median (full range (min-max))
Day 1	5.01 (3 to 12)	5.05 (4 to 12)	5 (5 to 6)
Day 28	4.5 (0 to 12)	5 (4 to 6.02)	4.5 (3 to 6)

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentrations (Cmax) - Part A and C

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End point title

Maximum Observed Plasma Concentrations (Cmax) - Part A and C ^[3]

End point description

Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. The analysis was performed in all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Pre-dose Day 1 to Day 10

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: nanogram/millilitre
geometric mean (geometric coefficient of variation)
Day 1	79.376 ( 37.6 )	201.498 ( 21.1 )	349.466 ( 23.2 )	791.317 ( 46.8 )	1155.448 ( 27.1 )	1515.389 ( 27.4 )	793.569 ( 21.2 )	1907.747 ( 38.9 )
Day 10	170.778 ( 20.8 )	337.379 ( 20.9 )	705.073 ( 15.4 )	1476.166 ( 17.2 )	2466.447 ( 22.1 )	2809.671 ( 25.5 )	1560.122 ( 17.4 )	3377.967 ( 32.8 )

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentrations (Cmax) - Part B

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End point title

Maximum Observed Plasma Concentrations (Cmax) - Part B

End point description

End point type

Secondary

End point timeframe

Pre-dose Day 1 to Day 28

End point values	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Number of subjects analysed	8	8	8
Units: nanogram/millilitre
geometric mean (geometric coefficient of variation)
Day 1	695.596 ( 9.52 )	770.975 ( 28.2 )	1493.336 ( 24 )
Day 28	1667.817 ( 30.2 )	1852 ( 33.6 )	3159.181 ( 22.1 )

No statistical analyses for this end point

Secondary: Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C

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End point title

Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C ^[4]

End point description

C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. The analysis was performed in all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Pre-dose Day 1 to Day 10

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: nanogram/millilitre
geometric mean (geometric coefficient of variation)
Day 1	34.946 ( 28.4 )	79.002 ( 27.2 )	154.5 ( 23.7 )	286.268 ( 15.6 )	482.349 ( 34.3 )	624.745 ( 24.6 )	339.173 ( 30.1 )	865.867 ( 41 )
Day 10	81.642 ( 23.1 )	138.775 ( 34.1 )	325.934 ( 19.4 )	713.077 ( 21.9 )	1150.397 ( 31.5 )	1288.985 ( 26.8 )	779.438 ( 24.6 )	1691.306 ( 29 )

No statistical analyses for this end point

Secondary: Plasma Concentration 24 hours Post-Dose (C24) - Part B

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End point title

Plasma Concentration 24 hours Post-Dose (C24) - Part B

End point description

End point type

Secondary

End point timeframe

Pre-dose Day 1 to Day 28

End point values	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Number of subjects analysed	8	8	8
Units: nanogram/millilitre
geometric mean (geometric coefficient of variation)
Day 1	462.312 ( 25 )	520.048 ( 27.7 )	899.364 ( 21.2 )
Day 28	1099.313 ( 37 )	1163.177 ( 30.9 )	2010.679 ( 19.9 )

No statistical analyses for this end point

Secondary: Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC(TAU)) - Part A and C

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End point title

Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC(TAU)) - Part A and C ^[5]

End point description

AUC(TAU) was defined as the area under the plasma concentration - time curve over the dosing interval. The analysis was performed in all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Pre-dose Day 1 to Day 10

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: nanogram*hour/millilitre
geometric mean (geometric coefficient of variation)
Day 1	1151.062 ( 32.2 )	2869.626 ( 21.3 )	5132.951 ( 21.5 )	10088.23 ( 23.1 )	17057.26 ( 29 )	21872.72 ( 27 )	10936.9 ( 29.9 )	26753.74 ( 35.9 )
Day 10	2720.237 ( 20.7 )	5168.553 ( 23.6 )	11751.82 ( 15.1 )	22984.83 ( 17.2 )	39341.11 ( 24.2 )	44182.4 ( 27 )	25556.64 ( 20.4 )	53972.71 ( 30.2 )

No statistical analyses for this end point

Secondary: Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC(TAU)) - Part B

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End point title

Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC(TAU)) - Part B

End point description

End point type

Secondary

End point timeframe

Pre-dose Day 1 to Day 28

End point values	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Number of subjects analysed	8	8	8
Units: nanogram*hour/millilitre
geometric mean (geometric coefficient of variation)
Day 1	12147.23 ( 15.2 )	12954.8 ( 26.2 )	24478.35 ( 22.6 )
Day 28	31406.32 ( 31.7 )	34225.08 ( 30.6 )	59915.72 ( 16.3 )

No statistical analyses for this end point

Secondary: Accumulation index (AI): Part A and C

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End point title

Accumulation index (AI): Part A and C ^[6]

End point description

AI was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose; also calculated for Cmax and C24. AI was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). The analysis was performed in PK population defined as all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Baseline and Day 10

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: Ratio
geometric mean (geometric coefficient of variation)
Cmax	2.152 ( 42.9 )	1.674 ( 31.1 )	2.018 ( 39.8 )	1.856 ( 33.6 )	2.135 ( 16.6 )	1.854 ( 22.7 )	1.966 ( 17.2 )	1.771 ( 42.6 )
C24	2.336 ( 21.9 )	1.757 ( 35 )	2.11 ( 29.5 )	2.491 ( 24.9 )	2.385 ( 25.1 )	2.063 ( 19.3 )	2.298 ( 28.4 )	1.953 ( 42.1 )
AUC	2.363 ( 25.9 )	1.801 ( 30.4 )	2.289 ( 39.7 )	2.278 ( 28.2 )	2.306 ( 19 )	2.02 ( 19.7 )	2.337 ( 26.1 )	2.017 ( 39 )

No statistical analyses for this end point

Secondary: Apparent total body clearance: Part A and C

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End point title

Apparent total body clearance: Part A and C ^[7]

End point description

Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). The analysis was performed in PK population defined as all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Baseline (Day 1) to Day 10

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: millilitre(s)/minute
geometric mean (geometric coefficient of variation)	30.635 ( 18.3 )	32.246 ( 28 )	28.364 ( 15.5 )	29.005 ( 18.8 )	33.892 ( 23.8 )	45.267 ( 34 )	26.086 ( 21.3 )	37.056 ( 33.7 )

No statistical analyses for this end point

Secondary: Degree of Fluctuation (DF): Part A and C

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End point title

Degree of Fluctuation (DF): Part A and C ^[8]

End point description

DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). The analysis was performed in PK population defined as all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Baseline (Day 1) to Day 10

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: Ratio
geometric mean (geometric coefficient of variation)	0.766 ( 29.4 )	0.912 ( 15.2 )	0.758 ( 20.2 )	0.78 ( 22.1 )	0.779 ( 28.5 )	0.818 ( 17.1 )	0.723 ( 13.7 )	0.727 ( 24.5 )

No statistical analyses for this end point

Secondary: Average observed plasma concentration at steady state (Css-avg): Part A and C

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End point title

Average observed plasma concentration at steady state (Css-avg): Part A and C ^[9]

End point description

Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). The analysis was performed in PK population defined as all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Baseline (Day 1) to Day 10

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: nanogram/millilitre
geometric mean (geometric coefficient of variation)	113.326 ( 20.7 )	215.111 ( 23.8 )	489.507 ( 15.1 )	956.222 ( 17.3 )	1639.471 ( 24.2 )	1841.413 ( 27 )	1065.435 ( 19.9 )	2256.793 ( 30.2 )

No statistical analyses for this end point

Secondary: Plasma half-life: Part A and C

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End point title

Plasma half-life: Part A and C ^[10]

End point description

Half-life of the terminal log-linear phase, (T-HALF), was calculated as ln2/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-HALF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). The analysis was performed in PK population defined as all subjects who received any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Baseline (Day 1) to Day 10

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate for the specified arm only.

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)
Number of subjects analysed	8	8	8	8	8	8	8	7
Units: hours
median (full range (min-max))	32.134 (25.45 to 46.45)	31.967 (23.97 to 43.02)	27.382 (24 to 41.59)	33.475 (25.79 to 42.39)	29.171 (24.32 to 38.02)	34.574 (29.01 to 39.69)	31.565 (24.39 to 51.64)	35.278 (26.65 to 38.71)

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline

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End point title

Number of Subjects With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline

End point description

Laboratory abnormalities were determined and graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004. Neutrophils + bands (absolute): <750/mm^3, Bilirubin (Total) : >2.5*upper limit of normal. The analysis was performed on all subjects who received at least 1 dose of study therapy.

End point type

Secondary

End point timeframe

Day 1 to up to end of the study (Day 42)

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: Subjects
Neutrophils (Absolute)	0	0	0	0	0	1	0	0	0	1	0	0	0	0
Bilirubin (Total)	0	0	0	0	0	0	2	5	3	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Significant Changes in Heart Rate

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End point title

Number of Subjects With Clinically Significant Changes in Heart Rate

End point description

Heart Rate were measured after the subject had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from baseline are based on matched postural positions and are calculated as parameter value - baseline parameter value: Value >100 and change from baseline > 30, or Value < 55 and change from baseline < -15. The analysis was performed on all subjects who received at least 1 dose of study therapy.

End point type

Secondary

End point timeframe

Day 1 to up to end of the study (Day 42)

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: Subjects	0	0	0	0	0	0	0	0	1	0	0	2	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Significant Changes in Electrocardiogram (ECG)

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End point title

Number of Subjects With Clinically Significant Changes in Electrocardiogram (ECG)

End point description

Subjects with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (msec): Value >200; QRS (msec): Value >120; QT (msec): Value >500 or change from baseline >30; QTcF (msec): Value >450 or change from baseline >30. The analysis was performed on all subjects who received at least 1 dose of study therapy.

End point type

Secondary

End point timeframe

Day 1 to up to end of the study (Day 42)

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: millisecond
number (not applicable)
PR > 200	1	1	1	0	0	2	0	1	1	1	1	0	0	0
QRS > 120	0	0	0	0	0	0	1	0	0	0	0	0	0	0
QT > 500	0	0	0	0	0	0	0	0	0	0	0	0	0	0
QTcB > 450	0	0	0	0	0	0	0	0	0	0	0	0	0	1
QTcF > 450	0	0	1	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Abnormal Changes in Physical Examination

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End point title

Number of Subjects With Abnormal Changes in Physical Examination

End point description

Subjects with abnormal changes in physical examination were evaluated. The analysis was performed on all subjects who received at least 1 dose of study therapy.

End point type

Secondary

End point timeframe

Day 1 to up to end of the study (Day 42)

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: Subjects
Height	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Weight	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Body mass index	0	0	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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End point title

Number of Subjects With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

End point description

Systolic BP [millimeter of mercury (mmHg)]: value >140 and change from baseline >20, or value <90 and change from baseline <-20; Diastolic BP (mmHg): value >90 and change from baseline >10, or value <55 and change from baseline <-10. The analysis was performed on all subjects who received at least 1 dose of study therapy.

End point type

Secondary

End point timeframe

Day 1 to up to end of the study (Day 42)

End point values	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade B	Placebo Clade C
Number of subjects analysed	8	8	8	8	8	8	8	8	4	8	8	7	12	4
Units: Subjects
SBP	0	0	0	0	0	0	0	1	0	0	0	0	0	0
DBP	0	1	1	0	0	0	0	1	0	1	1	0	1	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Day 1 to up to end of the study (Day 42)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

Part A-Group 1: BMS-955176 (5 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension once daily (QD) from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 2: BMS-955176 (10 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 3: BMS-955176 (20 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 4: BMS-955176 (40 mg)

Reporting group description

Subjects infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part A-Group 9: BMS-955176 (80 mg)

Reporting group description

Reporting group title

Part A-Group 10: BMS-955176 (120 mg)

Reporting group description

Reporting group title

Placebo Clade B

Reporting group description

Subjects infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part B-Group 5: BMS-955176 (40 mg) + Atazanavir

Reporting group description

Reporting group title

Part B-Group 6: BMS-955176 (40 mg) + Atazanavir+ Ritonavir

Reporting group description

Reporting group title

Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine

Reporting group description

Reporting group title

Part B-Group 12: BMS-955176 (80 mg) + Atazanavir

Reporting group description

Reporting group title

Part C-Group 8: BMS-955176 (40 mg)

Reporting group description

Subjects infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Part C-Group 13: BMS-955176 (120 mg)

Reporting group description

Subjects infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Reporting group title

Placebo Clade C

Reporting group description

Subjects infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Subjects were evaluated for a total period of 24 days from the day of first dose.

Serious adverse events	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Placebo Clade B	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir+ Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade C
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Part A-Group 1: BMS-955176 (5 mg)	Part A-Group 2: BMS-955176 (10 mg)	Part A-Group 3: BMS-955176 (20 mg)	Part A-Group 4: BMS-955176 (40 mg)	Part A-Group 9: BMS-955176 (80 mg)	Part A-Group 10: BMS-955176 (120 mg)	Placebo Clade B	Part B-Group 5: BMS-955176 (40 mg) + Atazanavir	Part B-Group 6: BMS-955176 (40 mg) + Atazanavir+ Ritonavir	Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine	Part B-Group 12: BMS-955176 (80 mg) + Atazanavir	Part C-Group 8: BMS-955176 (40 mg)	Part C-Group 13: BMS-955176 (120 mg)	Placebo Clade C
Total subjects affected by non serious adverse events
subjects affected / exposed	5 / 8 (62.50%)	5 / 8 (62.50%)	5 / 8 (62.50%)	6 / 8 (75.00%)	8 / 8 (100.00%)	7 / 8 (87.50%)	9 / 12 (75.00%)	8 / 8 (100.00%)	8 / 8 (100.00%)	4 / 4 (100.00%)	6 / 8 (75.00%)	7 / 8 (87.50%)	6 / 7 (85.71%)	3 / 4 (75.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Thrombophlebitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	1 / 8 (12.50%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	0	1	0	0	0	1	0	0	1	0	0	0	1
Nodule
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Malaise
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Chills
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	0	0	0	0	0
Asthenia
subjects affected / exposed	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Catheter site related reaction
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Sensation of foreign body
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Reproductive system and breast disorders
Dysmenorrhea
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Epistaxis
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	2 / 8 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	2	0	0	0	0	1	0	0	0	0	1	0
Nasal congestion
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	0	0	0
Cough
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Psychiatric disorders
Abnormal dreams
subjects affected / exposed	1 / 8 (12.50%)	0 / 8 (0.00%)	3 / 8 (37.50%)	1 / 8 (12.50%)	3 / 8 (37.50%)	3 / 8 (37.50%)	3 / 12 (25.00%)	3 / 8 (37.50%)	3 / 8 (37.50%)	0 / 4 (0.00%)	3 / 8 (37.50%)	2 / 8 (25.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	3	1	3	3	3	3	3	0	3	2	0	0
Sleep disorder
subjects affected / exposed	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	1	0	0	0	0
Nightmare
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	0 / 12 (0.00%)	2 / 8 (25.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	1	0	2	0	1	0	1	0	0
Agitation
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Mood swings
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Investigations
Blood bilirubin increased
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	6 / 8 (75.00%)	8 / 8 (100.00%)	4 / 4 (100.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	6	8	4	0	0	0	0
Weight decreased
subjects affected / exposed	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	1	0	1	0	0	0	0	0	0	0
Alanine aminotransferase increased
subjects affected / exposed	0 / 8 (0.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0	0	0	0
Blood bilirubin unconjugated increased
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Body temperature increased
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Intraocular pressure increased
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Neutrophil count decreased
subjects affected / exposed	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	2 / 8 (25.00%)	3 / 8 (37.50%)	0 / 8 (0.00%)	5 / 8 (62.50%)	4 / 8 (50.00%)	5 / 8 (62.50%)	5 / 12 (41.67%)	5 / 8 (62.50%)	3 / 8 (37.50%)	2 / 4 (50.00%)	4 / 8 (50.00%)	4 / 8 (50.00%)	2 / 7 (28.57%)	3 / 4 (75.00%)
occurrences all number	2	3	0	7	5	7	7	10	4	2	5	4	3	4
Dizziness
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	1	0	0	0
Poor quality sleep
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	2 / 8 (25.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	0
Dysaesthesia
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	0 / 4 (0.00%)	1 / 8 (12.50%)	2 / 8 (25.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	1	0	1	1	0	1	2	0	0
Eosinophilia
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Ear and labyrinth disorders
External ear pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Eye disorders
Ocular icterus
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)	3 / 8 (37.50%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	3	0	0	0	0	0
Eye pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Conjunctival haemorrhage
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Dry eye
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Eye irritation
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Foreign body sensation in eyes
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	2 / 8 (25.00%)	0 / 12 (0.00%)	3 / 8 (37.50%)	2 / 8 (25.00%)	2 / 4 (50.00%)	3 / 8 (37.50%)	0 / 8 (0.00%)	2 / 7 (28.57%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	1	2	0	5	3	3	10	0	3	0
Constipation
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	1 / 8 (12.50%)	1 / 8 (12.50%)	0 / 4 (0.00%)	1 / 8 (12.50%)	2 / 8 (25.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	1	1	1	0	1	2	0	1
Abdominal pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	1	0	0	0
Abdominal pain upper
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0	0	0
Abdominal pain lower
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	1	0
Nausea
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0	0	0
Vomiting
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0	0	0
Toothache
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Dry mouth
subjects affected / exposed	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	0	0	1	0	0	0	1	0	0	0
Abdominal distension
subjects affected / exposed	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Faeces hard
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Flatulence
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Gastrointestinal sounds abnormal
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Haemorrhoids thrombosed
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Lip swelling
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Hepatobiliary disorders
Jaundice
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 8 (25.00%)	4 / 8 (50.00%)	3 / 4 (75.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	4	3	0	0	0	0
Hyperbilirubinaemia
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	3 / 8 (37.50%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	0
Skin and subcutaneous tissue disorders
Night sweats
subjects affected / exposed	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	1 / 8 (12.50%)	1 / 12 (8.33%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	1	1	1	1	0	0	0	0	0	0
Pruritus
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 8 (25.00%)	2 / 8 (25.00%)	2 / 4 (50.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	2	2	2	0	0	0	1
Dermatitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	1	0
Acne
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Urticaria
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Rash
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0	0	0	0
Dermatitis allergic
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Dermatitis atopic
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Dry skin
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Eczema
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Erythema
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Rash papular
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Back pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1
Bone pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Groin pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Musculoskeletal stiffness
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Neck pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	2 / 8 (25.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 8 (12.50%)	0 / 8 (0.00%)	2 / 4 (50.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	2	0	2	1	0	2	0	0	0	0
Herpes zoster
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Candida infection
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Folliculitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Rhinitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	1	0	0	0
Gonorrhoea
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Hordeolum
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Pulpitis dental
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 4 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 8 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0
Increased appetite
subjects affected / exposed	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	1 / 4 (25.00%)	0 / 8 (0.00%)	0 / 8 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

28 Feb 2013

Revised criteria and timing of subject enrollment for Part B and C; fixed study dose for Part C; clarified blinding requirement in Part A; replaced 300 mg tenofovir tablet, QD, 200 mg emtricitabine capsule, QD with Truvada®; revised method of enrollment and randomisation, and method of emergency unblinding; and moved pregnancy test from Day 15 to Day 14; modified laboratory tests; revised the languages for the interim analysis; and include other study clarifications.

05 Sep 2013

The primary purpose of this amendment is to update contraception requirements for male subjects and women of childbearing potential who will enroll in the study.

24 Dec 2013

Included rationale for new Treatment Groups. Added a secondary objective and two exploratory objectives. Updated study design and duration.

27 Feb 2014

The primary purpose of this amendment is to add a troponin I test in laboratory test assessments and to clarify sample collection for lipid profile.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 with Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels from Baseline to Day 11

Primary: Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels from Baseline to Day 11

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C

Secondary: Number of Subjects With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the study

Secondary: Number of Subjects With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the study

Secondary: Maximum Decline from Baseline in Log10 HIV-1 Ribonucleic Acid (RNA)

Secondary: Maximum Decline from Baseline in Log10 HIV-1 Ribonucleic Acid (RNA)

Secondary: Time to Maximum Decline in Log 10 HIV-1 Ribonucleic Acid (RNA)

Secondary: Time to Maximum Decline in Log 10 HIV-1 Ribonucleic Acid (RNA)

Secondary: Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts

Secondary: Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts

Secondary: Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent

Secondary: Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) - Part B

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) - Part B

Secondary: Maximum Observed Plasma Concentrations (Cmax) - Part A and C

Secondary: Maximum Observed Plasma Concentrations (Cmax) - Part A and C

Secondary: Maximum Observed Plasma Concentrations (Cmax) - Part B

Secondary: Maximum Observed Plasma Concentrations (Cmax) - Part B

Secondary: Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C

Secondary: Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C

Secondary: Plasma Concentration 24 hours Post-Dose (C24) - Part B

Secondary: Plasma Concentration 24 hours Post-Dose (C24) - Part B

Secondary: Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC(TAU)) - Part A and C

Secondary: Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC(TAU)) - Part A and C

Secondary: Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC(TAU)) - Part B

Secondary: Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC(TAU)) - Part B

Secondary: Accumulation index (AI): Part A and C

Secondary: Accumulation index (AI): Part A and C

Secondary: Apparent total body clearance: Part A and C

Secondary: Apparent total body clearance: Part A and C

Secondary: Degree of Fluctuation (DF): Part A and C

Secondary: Degree of Fluctuation (DF): Part A and C

Secondary: Average observed plasma concentration at steady state (Css-avg): Part A and C

Secondary: Average observed plasma concentration at steady state (Css-avg): Part A and C

Secondary: Plasma half-life: Part A and C

Secondary: Plasma half-life: Part A and C

Secondary: Number of Subjects With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline

Secondary: Number of Subjects With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline

Secondary: Number of Subjects With Clinically Significant Changes in Heart Rate

Secondary: Number of Subjects With Clinically Significant Changes in Heart Rate

Secondary: Number of Subjects With Clinically Significant Changes in Electrocardiogram (ECG)

Secondary: Number of Subjects With Clinically Significant Changes in Electrocardiogram (ECG)

Secondary: Number of Subjects With Abnormal Changes in Physical Examination

Secondary: Number of Subjects With Abnormal Changes in Physical Examination

Secondary: Number of Subjects With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Secondary: Number of Subjects With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 with Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects