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GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944. Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1) Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in each treatment arm) will complete the study if both arms remain active throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2140944 1500 mg | Experimental | Subjects will receive single oral dose of GSK2140944 1500 mg. |
|
| GSK2140944 3000 mg | Experimental | Subjects will receive single oral dose of GSK2140944 3000 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2140944 | Drug | Immediate release capsules (pink hard gelatin size 00 capsule, with no external marking, filled with slightly agglomerated pale yellowish to grayish yellow powder) containing GSK2140944 500 mg and inactive formulation excipients. GSK2140944 will be administered orally once 1500 mg (3 capsules) or 3000 mg (6 capsules). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae at the Test-of-Cure Visit | 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. | Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | 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]. |
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Inclusion Criteria:
The subject is an adult male or female at least 18 years of age at the time of signing informed consent who meets one of the following criteria:
There is clinical suspicion that the subject has a urogenital gonococcal infection (e.g., prior culture, nucleic acid amplification test [NAAT] or Gram stain presumptive or positive for the presence of N. gonorrhoeae, or sexual contact with a partner diagnosed with gonorrhea within the past 14 days, as reported by the subject). Note: All subjects will be tested for N. gonorrhoeae, but these results will not be used to determine subject eligibility for enrollment in the study.
The subject has provided written, dated, informed consent and is willing and able to comply with the study protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fountain Valley | California | 92708 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36411033 | Derived | Scangarella-Oman NE, Hossain M, Perry CR, Tiffany C, Powell M, Swift B, Dumont EF. Dose selection for a phase III study evaluating gepotidacin (GSK2140944) in the treatment of uncomplicated urogenital gonorrhoea. Sex Transm Infect. 2023 Feb;99(1):64-69. doi: 10.1136/sextrans-2022-055518. Epub 2022 Nov 21. | |
| 30249694 | Derived |
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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.
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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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2140944 1500 mg | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From start of the study treatment until Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points | 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 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). | Baseline visit (Day 1) and Day 4 to Day 8 |
| Change From Baseline in Pulse Rate at the Indicated Time Points | 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). | Baseline visit (Day 1) and Day 4 to Day 8 |
| Change From Baseline in Temperature at the Indicated Time Points | 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). | Baseline visit (Day 1) and Day 4 to Day 8 |
| Change From Baseline in Respiratory Rate at the Indicated Time Points | 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). | Baseline visit (Day 1) and Day 4 to Day 8 |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 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). | Baseline visit and up to Day 8 |
| Number of Participants With Abnormal Physical Examination Finding | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Hemoglobin, Protein and Albumin at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Hematocrit at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Lymphocyte, Monocyte, Neutrophil Basophil, Eosinophil, Leukocyte and Platelet Count at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Bilirubin, Direct Bilirubin and Creatinine at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase and Alkaline Phosphatase at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Urea at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Erythrocytes at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Change From Baseline in Erythrocytes Mean Corpuscular Volume at Test-of-Cure Visit (Day 4 to 8) | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Number of Participants With Abnormal Urinalysis Dipstick Results | 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). | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
| Los Angeles |
| California |
| 90028 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90069 | United States |
| GSK Investigational Site | Palm Springs | California | 92262 | United States |
| GSK Investigational Site | San Francisco | California | 94103 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70119 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68114 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44109 | United States |
| GSK Investigational Site | Jenkintown | Pennsylvania | 19046 | United States |
| GSK Investigational Site | San Juan | 00927 | Puerto Rico |
| GSK Investigational Site | London | SW10 9NH | United Kingdom |
| Scangarella-Oman NE, Hossain M, Dixon PB, Ingraham K, Min S, Tiffany CA, Perry CR, Raychaudhuri A, Dumont EF, Huang J, Hook EW 3rd, Miller LA. Microbiological Analysis from a Phase 2 Randomized Study in Adults Evaluating Single Oral Doses of Gepotidacin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae. Antimicrob Agents Chemother. 2018 Nov 26;62(12):e01221-18. doi: 10.1128/AAC.01221-18. Print 2018 Dec. |
| 29617982 | Derived | Taylor SN, Morris DH, Avery AK, Workowski KA, Batteiger BE, Tiffany CA, Perry CR, Raychaudhuri A, Scangarella-Oman NE, Hossain M, Dumont EF. Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation. Clin Infect Dis. 2018 Aug 1;67(4):504-512. doi: 10.1093/cid/ciy145. |
| FG001 | GSK2140944 3000 mg | 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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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2140944 1500 mg | 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. |
| BG001 | GSK2140944 3000 mg | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae at the Test-of-Cure Visit | 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. | ME Population | Posted | Number | Participants | Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | 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. | Posted | Number | Participants | From start of the study treatment until Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points | 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 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). | Safety Population | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline visit (Day 1) and Day 4 to Day 8 |
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| Secondary | Change From Baseline in Pulse Rate at the Indicated Time Points | 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). | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline visit (Day 1) and Day 4 to Day 8 |
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| Secondary | Change From Baseline in Temperature at the Indicated Time Points | 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). | Safety Population | Posted | Mean | Standard Deviation | Celsius | Baseline visit (Day 1) and Day 4 to Day 8 |
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| Secondary | Change From Baseline in Respiratory Rate at the Indicated Time Points | 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). | Safety Population | Posted | Mean | Standard Deviation | Breaths per minute | Baseline visit (Day 1) and Day 4 to Day 8 |
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| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 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). | Safety Population | Posted | Number | Participants | Baseline visit and up to Day 8 |
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| Secondary | Number of Participants With Abnormal Physical Examination Finding | 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). | Safety Population | Posted | Number | Participants | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Hemoglobin, Protein and Albumin at Test-of-Cure Visit (Day 4 to 8) | 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). | Safety Population | Posted | Mean | Standard Deviation | Gram (G)/Liter (L) | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Hematocrit at Test-of-Cure Visit (Day 4 to 8) | 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). | Safety Population | Posted | Mean | Standard Deviation | Proportion of blood | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Lymphocyte, Monocyte, Neutrophil Basophil, Eosinophil, Leukocyte and Platelet Count at Test-of-Cure Visit (Day 4 to 8) | 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). | Safety Population | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Bilirubin, Direct Bilirubin and Creatinine at Test-of-Cure Visit (Day 4 to 8) | 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). | Safety Population | Posted | Mean | Standard Deviation | Micromole (UMOL)/ L | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase and Alkaline Phosphatase at Test-of-Cure Visit (Day 4 to 8) | 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). | Safety Population | Posted | Mean | Standard Deviation | International units (IU)/ L | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Urea at Test-of-Cure Visit (Day 4 to 8) | 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). | Safety Population | Posted | Mean | Standard Deviation | Millimole (MMOL)/L | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Erythrocytes at Test-of-Cure Visit (Day 4 to 8) | 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). | Posted | Mean | Standard Deviation | 10^12/L | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Test-of-Cure Visit (Day 4 to 8) | 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). | Safety Population | Posted | Mean | Standard Deviation | Picograms | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Change From Baseline in Erythrocytes Mean Corpuscular Volume at Test-of-Cure Visit (Day 4 to 8) | 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). | Safety Population | Posted | Mean | Standard Deviation | Femtoliters | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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| Secondary | Number of Participants With Abnormal Urinalysis Dipstick Results | 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). | Safety Population | Posted | Number | Participants | Baseline visit and Test-of-Cure visit (Day 4 to 8) |
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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).
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2140944 1500 mg | 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. | 0 | 52 | 22 | 52 | ||
| EG001 | GSK2140944 3000 mg | 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. | 0 | 53 | 28 | 53 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Faeces soft | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000612856 | gepotidacin |
Not provided
Not provided
Not provided
| Male |
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| American Indian or Alaska Native |
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| Central/South Asian Heritage |
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| Japanese/East Asian Heri. /South East Asian Heri. |
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| Native Hawaiian or other Pacific Islander |
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| White |
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| White & African American/African Heritage |
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| Unknown |
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| Microbio Response Urogenital Gonorrhea |
| 95 |
| 1-Sided |
| 95 |
| 84.7 |
GSK2140944 3000 mg |
| Superiority or Other |
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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