Clinical Trial Results:
A Phase II, Randomized, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
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Summary
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EudraCT number |
2015-005120-26 |
Trial protocol |
GB |
Global end of trial date |
02 Aug 2016
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Results information
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Results version number |
v2(current) |
This version publication date |
16 Jun 2017
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First version publication date |
02 Mar 2017
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Other versions |
v1 |
Version creation reason |
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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 |
116576
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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 |
GlaxoSmithKline
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Sponsor organisation address |
980 Great West Road, Brentford, Middlesex, United Kingdom,
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Public contact |
GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
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Scientific contact |
GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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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 |
02 Nov 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Aug 2016
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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 |
To demonstrate the effectiveness of single oral doses of GSK2140944 to treat adult subjects with uncomplicated urogenital gonorrhea caused by N. gonorrhoeae
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Protection of trial subjects |
Not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Apr 2015
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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 |
United Kingdom: 2
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Country: Number of subjects enrolled |
United States: 104
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Worldwide total number of subjects |
106
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EEA total number of subjects |
2
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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) |
105
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
This was a phase II, randomized, multicenter, open-label, dose ranging study evaluating the efficacy, safety and tolerability of gepotidacin therapy in participants with uncomplicated urogenital gonorrhea. The study duration was approximately 1 week with 2 planned study visits: Baseline (Day 1, pre-dose) and Test-of-Cure (TOC) (Day 4 to 8) visit. | |||||||||||||||
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Pre-assignment
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Screening details |
A total of 106 participants (par.) were randomized to receive GSK2140944 1500 milligrams (mg) or GSK2140944 3000 mg, of which 105 participants received any dose of study treatment and 1 par. was unable to swallow the capsule; therefore, did not receive study drug. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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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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GSK2140944 1500 mg | |||||||||||||||
Arm description |
Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
GSK2140944 1500 mg
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Investigational medicinal product code |
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Other name |
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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 |
GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each), orally dosed with food and 240 mL of water, additionally 100 mL of water was given to assist in swallowing a large number of capsules.
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Arm title
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GSK2140944 3000 mg | |||||||||||||||
Arm description |
Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
GSK2140944 3000 mg
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Investigational medicinal product code |
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Other name |
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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 |
GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each), orally dosed with food and 240 mL of water, additionally 100 mL of water was given to assist in swallowing a large number of capsules.
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Baseline characteristics reporting groups
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Reporting group title |
GSK2140944 1500 mg
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Reporting group description |
Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GSK2140944 3000 mg
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Reporting group description |
Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
GSK2140944 1500 mg
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Reporting group description |
Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit. | ||
Reporting group title |
GSK2140944 3000 mg
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Reporting group description |
Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit. | ||
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End point title |
Number of participants with culture-confirmed bacterial eradication of urogenital neisseria gonorrhoeae at the Test-of-Cure visit | |||||||||
End point description |
Pre-treatment urogenital, pharyngeal, and rectal swab specimens were obtained for bacteriological culture for neisseria (N.) gonorrhoeae at the Baseline visit. Test- of-Cure was defined by infection site (that is urogenital and, as appropriate, rectal and/or pharyngeal) as culture confirmed bacterial eradication of N. gonorrhoeae observed 3 to 7 days post-treatment. Pre-treatment urogenital specimens were obtained for nucleic acid amplification test (NAAT) assay to detect the presence of N. gonorrhoeae and chlamydia trachomatis at the Baseline visit. Only participants who had a pre-therapy N. gonorrhoeae isolate recovered from their urogenital specimen were evaluated. Microbiologically evaluable (ME) Population comprised of all randomized participants who had N. gonorrhoeae isolated from Baseline cultures of urogenital swab specimens, received any dose of gepotidacin, and returned for their TOC visit.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8)
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| Notes [1] - ME Population [2] - ME Population |
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Statistical analysis title |
Statistical analysis 2 | |||||||||
Statistical analysis description |
GSK2140944 3000 mg
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Comparison groups |
GSK2140944 1500 mg v GSK2140944 3000 mg
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
[3] | |||||||||
Method |
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Parameter type |
Microbio Response Urogenital Gonorrhea | |||||||||
Point estimate |
95
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Confidence interval |
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level |
95% | |||||||||
sides |
1-sided
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lower limit |
84.7 | |||||||||
upper limit |
- | |||||||||
| Notes [3] - Confidence interval has been presented for each Reporting Group |
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Statistical analysis title |
Statistical analysis 1 | |||||||||
Statistical analysis description |
GSK2140944 1500 mg
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Comparison groups |
GSK2140944 1500 mg v GSK2140944 3000 mg
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
[4] | |||||||||
Method |
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Parameter type |
Microbio Response Urogenital Gonorrhea | |||||||||
Point estimate |
97
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Confidence interval |
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level |
95% | |||||||||
sides |
1-sided
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lower limit |
85.1 | |||||||||
upper limit |
- | |||||||||
| Notes [4] - Confidence interval has been presented for each Reporting Group |
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End point title |
Number of participants with any adverse event (AE) or serious adverse event (SAE) | |||||||||||||||
End point description |
An AE is any untoward medical occurrence in a clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia (defined as alanine aminotransferase [ALT] >=3 times upper limit of normal [ULN] and bilirubin >=2 times ULN [>35 percent direct] [or ALT >=3 times ULN and international normalization ratio INR>1.5, if INR is measured].
Safety Population: comprised of all randomized participants who received any dose of study medication.
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End point type |
Secondary
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End point timeframe |
From start of the study treatment until Test-of-Cure visit (Day 4 to 8)
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| Notes [5] - Safety Population [6] - Safety Population |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Change from Baseline in systolic and diastolic blood pressure (BP) at the indicated time points | ||||||||||||||||||||||||
End point description |
BP was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendment 1 and up to TOC visit (Day 4 to 8).Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit (Day 1) and Day 4 to Day 8
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| Notes [7] - Safety Population [8] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change from Baseline in pulse rate at the indicated time points | ||||||||||||||||||
End point description |
Pulse rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit (Day 1) and Day 4 to Day 8
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| Notes [9] - Safety Population [10] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Baseline in temperature at the indicated time points | ||||||||||||||||||
End point description |
Temperature was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit (Day 1) and Day 4 to Day 8
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| Notes [11] - Safety Population [12] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Baseline in respiratory rate at the indicated time points | ||||||||||||||||||
End point description |
Respiratory rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements was obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC Visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit (Day 1) and Day 4 to Day 8
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| Notes [13] - Safety Population [14] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of participants with abnormal electrocardiogram (ECG) findings | |||||||||||||||||||||||||||
End point description |
A single 12-lead ECGs were obtained at the Baseline, 2 hour post-dose, and at the TOC (Day 4 to 8) visit using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. ECG was obtained prior to any vital sign measurements or blood draws scheduled on the same assessment day. For participants enrolled under protocol amendment 1, ECG was measured at Baseline visit Day 1 (pre-dose) only. ECG assessments were presented as abnormal-clinically significant (CS) and abnormal-not clinically significant (NCS) at the indicated time points. Only those participants available at the specified time points were analyzed (represented by n=X , X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and up to Day 8
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| Notes [15] - Safety Population [16] - Safety Population |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Number of participants with abnormal physical examination finding | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Physical examination of respiratory, cardiovascular, abdomen, gastrointestinal, urogenital systems, pharyngeal and rectal examinations with collections of microbiology specimen was performed at the Baseline and TOC (Day 4 to 8) visit. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [17] - Safety Population [18] - Safety Population |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in hemoglobin, protein and albumin at Test-of-Cure visit (Day 4 to 8) | |||||||||||||||||||||
End point description |
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hemoglobin, total protein and albumin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [19] - Safety Population [20] - Safety Population |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change from Baseline in hematocrit at Test-of-Cure visit (Day 4 to 8) | ||||||||||||
End point description |
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hematocrit. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [21] - Safety Population [22] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in lymphocyte, monocyte, neutrophil basophil, eosinophil, leukocyte and platelet count at Test-of-Cure visit (Day 4 to 8) | |||||||||||||||||||||||||||||||||
End point description |
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate neutrophil, lymphocyte, basophil, eosinophil, monocyte, leukocyte and platelet count. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [23] - Safety Population [24] - Safety Population |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in bilirubin, direct bilirubin and creatinine at Test-of-Cure visit (Day 4 to 8) | |||||||||||||||||||||
End point description |
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate bilirubin, direct bilirubin and creatinine. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [25] - Safety Population [26] - Safety Population |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change from Baseline in alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase at Test-of-Cure visit (Day 4 to 8) | |||||||||||||||||||||
End point description |
Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [27] - Safety Population [28] - Safety Population |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change from Baseline in chloride, calcium, glucose, potassium, sodium and urea at Test-of-Cure visit (Day 4 to 8) | ||||||||||||||||||||||||||||||
End point description |
Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate chloride, calcium, glucose, potassium, sodium and urea (blood urea nitrogen). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [29] - Safety Population [30] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in erythrocytes at Test-of-Cure visit (Day 4 to 8) | ||||||||||||
End point description |
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes (red blood cell count). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [31] - Safety Population [32] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in erythrocytes mean corpuscular hemoglobin at Test-of-Cure visit (Day 4 to 8) | ||||||||||||
End point description |
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular hemoglobin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [33] - Safety Population [34] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in erythrocytes mean corpuscular volume at Test-of-Cure visit (Day 4 to 8) | ||||||||||||
End point description |
Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular volume. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [35] - Safety Population [36] - Safety Population |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of participants with abnormal urinalysis dipstick results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Dipstick urinalysis was done for glucose, ketones, occult blood, protein, potential hydrogen (pH) and specific gravity at Baseline visit Day 1 (pre-dose) and Test-of-Cure visit (Day 4 to 8). Results were presented as negative (normal) or other findings reported only if observed under microscopic examination trace, 1+, 2+, 3+, 4+ and 5+ glucose, ketones, occult blood and protein. pH results were categorized as per their pH values. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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End point type |
Secondary
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End point timeframe |
Baseline visit and Test-of-Cure visit (Day 4 to 8)
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| Notes [37] - Safety Population [38] - Safety Population |
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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 |
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment (Day1) until Test-of-Cure visit (Day 4 to 8).
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Adverse event reporting additional description |
On-treatment SAEs and non-serious (AEs) are reported for Safety Population which comprised of all randomized participants who received any dose of study medication.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.1
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Reporting groups
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Reporting group title |
GSK2140944 1500 mg
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Reporting group description |
Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GSK2140944 3000 mg
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Reporting group description |
Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
04 Apr 2016 |
Added optional interim analyses for success or futility. Removed the 2-hour post-dose ECG, vital sign measurements, and PK requirements and removed the ECG at the Test-of-Cure (Day 4 to 8) visit. Incorporated Protocol Administration Letters 1, 2, 3, and 4.Clarified that treatment for Chlamydia trachomatis at the Test-of-Cure (Day 4 to 8) visit should be administered after all study procedures have been completed. Clarified that the laboratory manual, in addition to the study procedures manual, provides instructions for sample collection, processing, and shipment. Updated medical monitor information. Updated the list of authors. Updated the investigator’s brochure (IB) document number and added IB supplement 1 reference. Updated formatting and stylistic inconsistencies and minor administrative edits. |
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Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
