Trial · NCT04493931
Drug-drug Interaction Study of Gepotidacin
NCT04493931, Phase 1, Completed, GlaxoSmithKline; results first posted 2022-03-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Drug-drug Interaction Study of Gepotidacin. Trials, record NCT04493931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04493931
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug-drug Interaction Study of Gepotidacin
- NCT number
- NCT04493931
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 64 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Bacterial
- Interventions
- Gepotidacin, Cimetidine, Rifampicin, Midazolam, Digoxin, Placebo matching to gepotidacin
- First posted
- 2020-07-30
- Last updated
- 2022-03-04
- Results first posted
- 2022-03-04
Source ClinicalTrials.gov
Registered outcomes139
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric least square (LS) mean and 90 percent (%) confidence interval (CI) of the geometric LS means have been presented. |
| Primary | Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Primary | Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Primary | Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Primary | Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Primary | Cohort 2: Cmax of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Primary | Cohort 2: Lag Time Before Observation of Drug Concentrations (Tlag) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Primary | Cohort 2: Tmax of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Primary | Cohort 2: AUC(0-t) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Primary | Cohort 2: AUC(0-infinity) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
1 to 10 of 139Source ClinicalTrials.gov
See all 139 registered outcomesOutcomes139
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population comprised of all participants in the Pharmacokinetic Population (received at least 1 dose of study intervention and had at least 1 non-missing plasma or urine pharmacokinetic concentration) who received study intervention for whom valid and evaluable plasma or urine pharmacokinetic parameters were derived. | Micrograms per milliliter | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Hours | MEDIAN |
| PRIMARY | Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Hours | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Hours*micrograms per milliliter | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Hours* micrograms per milliliter | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Cohort 2: Cmax of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Micrograms per milliliter | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Cohort 2: Lag Time Before Observation of Drug Concentrations (Tlag) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Hours | MEDIAN |
| PRIMARY | Cohort 2: Tmax of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Hours | MEDIAN |
| PRIMARY | Cohort 2: AUC(0-t) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Hours*micrograms per milliliter | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Cohort 2: AUC(0-infinity) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Pharmacokinetic Parameter Population | Hours*micrograms per milliliter | GEOMETRIC_LEAST_SQUARES_MEAN |
1 to 10 of 139Source ClinicalTrials.gov
See all 139 outcomesResults by group1,440
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg | 4.817 | 90% Confidence Interval 4.006 to 5.793 | Micrograms per milliliter | |
| Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | 4.548 | 90% Confidence Interval 3.756 to 5.506 | Micrograms per milliliter | |
| Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg | 2.500 | Full Range 1.00 to 4.00 | Hours | |
| Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | 2.500 | Full Range 1.00 to 4.00 | Hours | |
| Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg | 11.344 | 90% Confidence Interval 10.282 to 12.516 | Hours | |
| Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | 12.415 | 90% Confidence Interval 11.207 to 13.754 | Hours | |
| Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg | 20.3 | 90% Confidence Interval 17.7 to 23.3 | Hours*micrograms per milliliter | |
| Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | 23.4 | 90% Confidence Interval 20.4 to 26.9 | Hours*micrograms per milliliter | |
| Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg | 20.6 | 90% Confidence Interval 18.0 to 23.6 | Hours* micrograms per milliliter | |
| Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma | Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | 23.9 | 90% Confidence Interval 20.8 to 27.4 | Hours* micrograms per milliliter |
1 to 10 of 1,440Source ClinicalTrials.gov
See all 1,440 results by groupParticipant flow378
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort1:Treatment Period 1(Up to 3 Days) | STARTED | Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg | 14 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | STARTED | Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin | 0 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | STARTED | Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam | 0 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | STARTED | Cohort 3: Gepotidacin 3000 mg + Digoxin + Midazolam/Digoxin+Midazolam | 0 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | STARTED | Cohort 4:Gepotidacin 1500 mg Fed/Gepotidacin 1500 mg Fasted/Gepotidacin 3000 mg Fed | 0 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | STARTED | Cohort 4:Gepotidacin 1500 mg Fasted/Gepotidacin 1500 mg Fed/Gepotidacin 3000 mg Fed | 0 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | STARTED | Cohort 4: Placebo Fed/ Placebo Fasted/ Placebo Fed | 0 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | COMPLETED | Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg | 13 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | COMPLETED | Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin | 0 | |
| Cohort1:Treatment Period 1(Up to 3 Days) | COMPLETED | Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam | 0 |
1 to 10 of 378Source ClinicalTrials.gov
See all 378 participant flowAdverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1: Gepotidacin 1500 mg | 0 | 14 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | 0 | 13 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 2: Period 1: Gepotidacin 1500 mg | 2 | 17 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 2: Period 2 (Days 1 to 7) Rifampicin 600 mg | 0 | 17 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 2: Period 2 (Days 8 to 9) Gepotidacin 1500 mg + Rifampicin 600 mg | 2 | 14 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 3: Digoxin 0.5 mg + Midazolam 2 mg | 0 | 19 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 3:Gepotidacin 3000 mg + Digoxin 0.5 mg + Midazolam 2 mg | 6 | 18 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 4: Placebo | 0 | 3 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 4: Gepotidacin 1500 mg Fed | 0 | 11 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 4: Gepotidacin 1500 mg Fasted | 0 | 11 | 0 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Gepotidacin 1500 mg | 0 | 14 |
| Total, all-cause mortality | Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | 0 | 13 |
| Total, all-cause mortality | Cohort 2: Period 1: Gepotidacin 1500 mg | 0 | 17 |
| Total, all-cause mortality | Cohort 2: Period 2 (Days 1 to 7) Rifampicin 600 mg | 0 | 17 |
| Total, all-cause mortality | Cohort 2: Period 2 (Days 8 to 9) Gepotidacin 1500 mg + Rifampicin 600 mg | 0 | 14 |
| Total, all-cause mortality | Cohort 3: Digoxin 0.5 mg + Midazolam 2 mg | 0 | 19 |
| Total, all-cause mortality | Cohort 3:Gepotidacin 3000 mg + Digoxin 0.5 mg + Midazolam 2 mg | 0 | 18 |
| Total, all-cause mortality | Cohort 4: Placebo | 0 | 3 |
| Total, all-cause mortality | Cohort 4: Gepotidacin 1500 mg Fed | 0 | 11 |
| Total, all-cause mortality | Cohort 4: Gepotidacin 1500 mg Fasted | 0 | 11 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04493931
GET https://conductscience.org/api/trials/v1/NCT04493931/registered?page=2