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NCT02729038 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02729038 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 32 participants.
The verdict
NCT02729038, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required. The objective of this study is to compare the pharmacokinetics of gepotidacin administered as a 750 milligram (mg) intravenous (IV) dose in normal healthy subjects compared with subjects with mild, moderate, and severe renal impairment, and with subjects with end stage renal disease (ESRD). This is a Phase I, nonrandomized, open-label, parallel-group, multi-center, multi-part study. In Part 1, up to 16 subjects with normal renal function will be matched to approximately 8 subjects with moderate renal impairment, and approximately 8 subjects with severe renal impairment and/or subjects with ESRD not on hemodialysis for a total of approximately 32 subjects. In Part 2 (optional), approximately 4 to 8 subjects with normal renal function (if enrolled), approximately 4 to 8 subjects with mild renal impairment, and approximately 4 to 8 subjects with ESRD on hemodialysis will be enrolled for a total of approximately 12 to 24 subjects. The duration from Screening to the Follow-up Visit will be approximately 44 days for Part 1 and approximately 50 days for Part 2.
Interventions
- DRUG Gepotidacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-06-29 |
| Est. Completion | 2017-06-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02729038
The ClinicalTrials.gov registry entry for NCT02729038 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gepotidacin is the first listed.
NCT02729038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02729038 about?
NCT02729038 is a clinical study titled "Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function". This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required. The objective of this study is to compare the pharmacokinetics of gepotidacin administered as ...
What is the current status of trial NCT02729038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2016-06-29. Estimated completion is 2017-06-20.
What interventions are being tested in trial NCT02729038?
The interventions under investigation include: Gepotidacin (DRUG).
Who is sponsoring clinical trial NCT02729038?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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