Trial · NCT03568942
Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)
NCT03568942, Phase 2, Completed, GlaxoSmithKline; results first posted 2020-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis). Trials, record NCT03568942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03568942
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)
- NCT number
- NCT03568942
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Bacterial
- Interventions
- Gepotidacin
- First posted
- 2018-06-26
- Last updated
- 2020-06-29
- Results first posted
- 2020-01-07
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population consisted of all participants who received gepotidacin 1500 mg BID through the completion of all PK collections for whom valid and evaluable plasma PK parameters were derived for gepotidacin. |
| Primary | Maximum Plasma Concentration (Cmax) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| Primary | Time of Occurrence of Cmax (Tmax) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| Primary | Apparent Steady State Clearance (CLss/F) of Gepotidacin | Day 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. CLss/F was calculated as Dose divided by AUC(0-tau). |
| Primary | Accumulation Ratio (Ro) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Accumulation ratio (Ro) was calculated as ratio of AUC(0-tau) at Day 4 to AUC(0-tau) at Day 1. |
| Primary | Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Days 1 to 5: Pre-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| Secondary | Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Ae12hours was calculated by adding all the fractions of drug collected over all the allotted time intervals. |
| Secondary | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | Ae(t1-t2) measure the amount of drug excreted in urine in a time intervals 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose on Days 1 and 4. The PK parameters were calculated by standard non-compartmental analysis. |
| Secondary | Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. fe% was calculated as fe% = (Ae 12 hours/Dose) multiply by 100. The PK parameters were calculated by standard non-compartmental analysis. |
| Secondary | Renal Clearance (CLr) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. CLr was calculated as CLr = Ae 12 hours/AUC(0-tau). The PK parameters were calculated by standard non-compartmental analysis. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Hours* nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Maximum Plasma Concentration (Cmax) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Time of Occurrence of Cmax (Tmax) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Hours | MEDIAN |
| PRIMARY | Apparent Steady State Clearance (CLss/F) of Gepotidacin | Day 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. Only those participants with data available at the indicated time points were analyzed. | Liters per hour | GEOMETRIC_MEAN |
| PRIMARY | Accumulation Ratio (Ro) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. Only those participants with data available at the indicated time points were analyzed. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Days 1 to 5: Pre-dose | PK Parameter Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | mg | GEOMETRIC_MEAN |
| SECONDARY | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | mg | GEOMETRIC_MEAN |
| SECONDARY | Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Percentage of dose | GEOMETRIC_MEAN |
| SECONDARY | Renal Clearance (CLr) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Liters per hour | GEOMETRIC_MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group195
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin | Gepotidacin 1500 mg | Day 1, n=20 | 20236.2 | Geometric Coefficient of Variation 28.6 | Hours* nanogram per milliliter (h*ng/mL) |
| Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin | Gepotidacin 1500 mg | Day 4, n=21 | 29313.8 | Geometric Coefficient of Variation 31.8 | Hours* nanogram per milliliter (h*ng/mL) |
| Maximum Plasma Concentration (Cmax) of Gepotidacin | Gepotidacin 1500 mg | Day 1, n=20 | 5891 | Geometric Coefficient of Variation 47.3 | Nanogram per milliliter (ng/mL) |
| Maximum Plasma Concentration (Cmax) of Gepotidacin | Gepotidacin 1500 mg | Day 4, n=21 | 8437 | Geometric Coefficient of Variation 38.0 | Nanogram per milliliter (ng/mL) |
| Time of Occurrence of Cmax (Tmax) of Gepotidacin | Gepotidacin 1500 mg | Day 1, n=20 | 1.500 | Full Range 0.47 to 3.07 | Hours |
| Time of Occurrence of Cmax (Tmax) of Gepotidacin | Gepotidacin 1500 mg | Day 4, n=21 | 1.917 | Full Range 0.45 to 4.12 | Hours |
| Apparent Steady State Clearance (CLss/F) of Gepotidacin | Gepotidacin 1500 mg | 51.17 | Geometric Coefficient of Variation 31.8 | Liters per hour | |
| Accumulation Ratio (Ro) of Gepotidacin | Gepotidacin 1500 mg | 1.402 | Geometric Coefficient of Variation 20.4 | Ratio | |
| Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Gepotidacin 1500 mg | Day 1, Pre-dose, n=22 | NA | Geometric Coefficient of Variation NA | ng/mL |
| Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Gepotidacin 1500 mg | Day 2, Pre-dose, n=21 | 620.5 | Geometric Coefficient of Variation 62.3 | ng/mL |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gepotidacin 1500 mg | 22 | |
| Overall Study | COMPLETED | Gepotidacin 1500 mg | 20 | |
| Overall Study | NOT COMPLETED | Gepotidacin 1500 mg | 2 |
Source ClinicalTrials.gov
Adverse events9
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 | Gepotidacin 1500 mg | 18 | 22 | 22 |
| other | Nausea | Gastrointestinal disorders | Gepotidacin 1500 mg | 17 | 22 | 18 |
| other | Vomiting | Gastrointestinal disorders | Gepotidacin 1500 mg | 5 | 22 | 5 |
| other | Viral upper respiratory tract infection | Infections and infestations | Gepotidacin 1500 mg | 2 | 22 | 2 |
| other | Vulvovaginal mycotic infection | Infections and infestations | Gepotidacin 1500 mg | 2 | 22 | 2 |
| other | Headache | Nervous system disorders | Gepotidacin 1500 mg | 5 | 22 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Gepotidacin 1500 mg | 2 | 22 | 2 |
| other | Chest discomfort | General disorders | Gepotidacin 1500 mg | 2 | 22 | 2 |
| serious | Major depression | Psychiatric disorders | Gepotidacin 1500 mg | 1 | 22 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gepotidacin 1500 mg | 0 | 22 |
| Total, other adverse events | Gepotidacin 1500 mg | 21 | 22 |
| Total, serious adverse events | Gepotidacin 1500 mg | 1 | 22 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03568942
GET https://conductscience.org/api/trials/v1/NCT03568942/registered?page=2