Clinical Trial Results:
A Phase 1, Open-Label, Randomized, 2-Period, 2-Sequence, Crossover Study to Evaluate the Bioequivalence of Bosutinib Pediatric Capsule and the Commercial Tablet Formulations in Healthy Participants Under Fed Condition
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Summary
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EudraCT number |
2020-002782-34 |
Trial protocol |
NL |
Global end of trial date |
15 Jan 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jan 2022
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First version publication date |
29 Jan 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
B1871061
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000727-PIP01-09 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Jan 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Jan 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Jan 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this pivotal bioequivalence study was to support the bridging of the approved immediate release film coated tablet to the proposed age-appropriate capsule formulation in healthy subjects.
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Protection of trial subjects |
This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP)
Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Sep 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 66
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Worldwide total number of subjects |
66
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EEA total number of subjects |
66
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
66
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 66 subjects were enrolled and treated in this study. There were 2 periods in this study, which were separated by at least 14 days washout. No subjects discontinued in Period 1, 5 subjects discontinued during washout period, and 3 subjects discontinued in Period 2. A total of 58 subjects completed the study. | |||||||||||||||||||||
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Period 1
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Period 1 title |
Period 1
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1: PF-05208763 Capsule First Then Tablet | |||||||||||||||||||||
Arm description |
Subjects received PF-05208763 capsule 100 mg single dose (SD) on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 2. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
PF-05208763
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Investigational medicinal product code |
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Other name |
Bosutinib
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
100 mg single dose
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Arm title
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Treatment Sequence 2: PF-05208763 Tablet First Then Capsule | |||||||||||||||||||||
Arm description |
Subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 2. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
PF-05208763
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Investigational medicinal product code |
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Other name |
Bosutinib
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
100 mg single dose
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Period 2
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Period 2 title |
Washout Period
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Is this the baseline period? |
No | |||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1: PF-05208763 Capsule First Then Tablet | |||||||||||||||||||||
Arm description |
Subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 2. | |||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment Sequence 2: PF-05208763 Tablet First Then Capsule | |||||||||||||||||||||
Arm description |
Subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 2. | |||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 3
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Period 3 title |
Period 2
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Is this the baseline period? |
No | |||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1: PF-05208763 Capsule First Then Tablet | |||||||||||||||||||||
Arm description |
Subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 2. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
PF-05208763
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Investigational medicinal product code |
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Other name |
Bosutinib
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
100 mg single dose
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Arm title
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Treatment Sequence 2: PF-05208763 Tablet First Then Capsule | |||||||||||||||||||||
Arm description |
Subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 2. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
PF-05208763
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Investigational medicinal product code |
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Other name |
Bosutinib
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
100 mg single dose
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Baseline characteristics reporting groups
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Reporting group title |
Period 1
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Reporting group description |
A total of 33 subjects who were assigned to Treatment Sequence 1 received PF-05208763 capsule 100 mg SD on Day 1 in Period 1. A total of 33 subjects who were assigned to Treatment Sequence 2 received PF-05208763 tablet 100 mg SD on Day 1 in Period 1. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment Sequence 1: PF-05208763 Capsule First Then Tablet
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Reporting group description |
Subjects received PF-05208763 capsule 100 mg single dose (SD) on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 2. | ||
Reporting group title |
Treatment Sequence 2: PF-05208763 Tablet First Then Capsule
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Reporting group description |
Subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 2. | ||
Reporting group title |
Treatment Sequence 1: PF-05208763 Capsule First Then Tablet
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Reporting group description |
Subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 2. | ||
Reporting group title |
Treatment Sequence 2: PF-05208763 Tablet First Then Capsule
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Reporting group description |
Subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 2. | ||
Reporting group title |
Treatment Sequence 1: PF-05208763 Capsule First Then Tablet
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Reporting group description |
Subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 2. | ||
Reporting group title |
Treatment Sequence 2: PF-05208763 Tablet First Then Capsule
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Reporting group description |
Subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 1, following by a washout period of at least 14 days. Then subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 2. | ||
Subject analysis set title |
Treatment A: PF-05208763 100 mg SD Capsule
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects received PF-05208763 capsule 100 mg SD on Day 1 in Period 1 or 2.
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Subject analysis set title |
Treatment B: PF-05208763 100 mg SD Tablet
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects received PF-05208763 tablet 100 mg SD on Day 1 in Period 1 or 2.
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End point title |
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Bosutinib [1] | ||||||||||||
End point description |
AUCinf of bosutinib 100 mg SD when administered as a capsule and tablet formulation under fed condition. The analysis population for this endpoint included all subjects randomized and treated who had at least 1 of the pharmacokinetics (PK) parameters of primary interest in at least 1 treatment period.
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End point type |
Primary
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End point timeframe |
Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post dose on Day 1 in each treatment period
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| 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: No statistical analysis was planned for this endpoint |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Maximum Plasma Concentration (Cmax) of Bosutinib [2] | ||||||||||||
End point description |
Cmax of bosutinib 100 mg SD when administered as a capsule and tablet formulation under fed condition. The analysis population for this endpoint included all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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End point type |
Primary
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End point timeframe |
Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post dose on Day 1 in each treatment period
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| Notes [2] - 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: No statistical analysis was planned for this endpoint |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Area Under the Plasma Concentration Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Bosutinib | ||||||||||||
End point description |
AUClast of bosutinib 100 mg SD administered as capsule and tablet formulation under fed condition. The analysis population for this endpoint included all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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End point type |
Secondary
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End point timeframe |
Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post dose on Day 1 in each treatment period
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time for Cmax (Tmax) of Bosutinib | ||||||||||||
End point description |
Tmax of bosutinib 100 mg SD administered as capsule and table formulation under fed condition. The analysis population for this endpoint included all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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End point type |
Secondary
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End point timeframe |
Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post dose on Day 1 in each treatment period
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Apparent Clearance After Oral Dose (CL/F) of Bosutinib | ||||||||||||
End point description |
CL/F of bosutinib 100 mg SD administered as capsule and table formulation under fed condition. CL/F was calculated as Dose/AUCinf after oral dose. AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. The analysis population for this endpoint included all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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End point type |
Secondary
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End point timeframe |
Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post dose on Day 1 in each treatment period
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Apparent Volume of Distribution After Oral Dose (Vz/F) of Bosutinib | ||||||||||||
End point description |
Vz/F of bosutinib 100 mg SD administered as capsule and table formulation under fed condition. Vz/F was calculated as Dose/(AUCinf*kel) after oral dose. AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. kel was defined as the terminal phase rate constant calculated by a linear regression through at least 3 data points in the terminal phase of the log-linear concentration-time curve. The analysis population for this endpoint included all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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End point type |
Secondary
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End point timeframe |
Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post dose on Day 1 in each treatment period
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Terminal Elimination Half-Life (t1/2) of Bosutinib | ||||||||||||
End point description |
t1/2 of bosutinib 100 mg SD administered as capsule and table formulation under fed condition. t1/2 was calculated as Log e(2)/kel. kel was defined as the terminal phase rate constant calculated by a linear regression through at least 3 data points in the terminal phase of the log-linear concentration-time curve. The analysis population for this endpoint included all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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End point type |
Secondary
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End point timeframe |
Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post dose on Day 1 in each treatment period
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With Laboratory Abnormalities | ||||||||||||||||||||||||||||||||||||
End point description |
Evaluated laboratory parameters included hematology (lymphocytes < 0.8*lower limit of normal [LLN] or >1.2*upper limit of normal [ULN], neutrophils <0.8*LLN, and eosinophils >1.2*ULN), clinical chemistry (bilirubin >1.5*ULN and urate >1.2*ULN), and urinalysis (ketones >=1, urine hemoglobin >=1, and leukocyte esterase >=1). The analysis population for this endpoint included all subjects randomly assigned to study intervention and who have taken at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
Post first dose up to Day 7 in Period 2 or early termination (maximum of 22 days)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) | |||||||||||||||||||||||||||
End point description |
AE = any untoward medical occurrence in subject who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were adjudicated according to the investigator's assessment. Treatment-related AEs and SAEs were determined by the investigator. The analysis population for this endpoint included all subjects randomly assigned to study intervention and who have taken at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
Post first dose up to 28 days after end of treatment (maximum of 43 days)
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Electrocardiograms (ECGs) Meeting Categorical Criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Categorical criteria included PR interval >=300 msec, percent change (Pctchg) of PR interval >=25% for baseline value of >200 msec and >=50% for baseline value of <=200 msec; QRS interval >=140 msec, Pctchg of QRS interval >=50%; maximum of QT interval of >= 500 msec; maximum QTcB interval (Bazett's Correction) of 450 msec to <480 msec, 480 msec to <500 msec, >=500 msec, and a maximum change of <=30change<60 or >=60 msec from baseline; maximum QTcF interval (Friderecia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec, >=500 msec, and a maximum change of <=30change<60 or >=60 msec from baseline. The analysis population for this endpoint included all subjects randomly assigned to study intervention and who had taken at least 1 dose of study intervention and had at least 1 ECG assessment undertaken post dose.
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End point type |
Secondary
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End point timeframe |
Post first dose up to Day 7 in Period 2 or early termination (maximum of 22 days)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Vital Signs Meeting Categorical Criteria | |||||||||||||||||||||||||||||||||
End point description |
Categorical criteria were defined as diastolic blood pressure (mm Hg): value <50 mm Hg, increase >=20 mm Hg, or decrease >=20 mm Hg; pulse rate(bpm): value <40 bpm and value>120 bpm; systolic blood pressure (mm Hg): value <90 mm Hg, increase >=30 mm Hg, or decrease >=30 mm Hg. The analysis population for this endpoint included all subjects randomly assigned to study intervention and who had taken at least 1 dose of study intervention and had at least 1 assessment undertaken post treatment.
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End point type |
Secondary
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End point timeframe |
Post first dose up to Day 7 in Period 2 or early termination (maximum of 22 days)
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Post first dose up to 28 days after last dose of study intervention (maximum of 43 days)
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Adverse event reporting additional description |
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.1
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Reporting groups
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Reporting group title |
Treatment B: PF-05208763 100 mg SD Tablet
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Reporting group description |
Subject received PF-05208763 tablet 100 mg SD on Day 1 in Period 1 or 2. | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment A: PF-05208763 100 mg SD Capsule
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Reporting group description |
Subject received PF-05208763 capsule 100 mg SD on Day 1 in Period 1 or 2. | |||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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24 Aug 2020 |
An additional PK sampling time at 144 hours postdose was added to cover at least 3 terminal half-lives of bosutinib in healthy subjects. This sample will be collected as an outpatient visit on Day 7. In addition, the PK sampling time at 16 hours post dose was removed as there are adequate number of PK samples collected to fully characterize the PK of bosutinib. Accordingly, the following sections were updated in the protocol: Section 1.1, Section 1.3, Section 4.1, and Section 8. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
