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NCT03562117 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
A Phase 1 study of Infections, Bacterial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT03562117: Completed Phase 1 study of Infections, Bacterial, sponsored by GlaxoSmithKline.
NCT03562117 is a Phase 1 study of Infections, Bacterial that has completed, run by GlaxoSmithKline. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03562117, a Phase 1 study of Infections, Bacterial, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a two-part study which will evaluate the PK, safety, and tolerability of a single 1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in subjects with mild, moderate, and severe hepatic impairment. In Part 1, subjects with moderate hepatic impairment and subjects with normal hepatic function will be enrolled. Matching subjects with normal hepatic function in Part 1 (Group D), will be enrolled following the completion of all Day 3 assessments of the respective matched, hepatically impaired subject. In Part 2, subjects with mild (optional) and severe hepatic impairment and subjects with normal hepatic function will be enrolled concurrently based on the PK, safety, and tolerability data of Part 1. Subjects with mild hepatic impairment, may be studied if there is a significant difference in PK between subjects with moderate hepatic impairment and subjects with normal hepatic function. Subjects with severe hepatic impairment, will be studied in Part 2, provided that, the PK objectives are achieved in Part 1. A totals of 48 subjects, are planned to be enrolled in the study. The study duration is approximately of 44 days from Screening to Follow-up visit. The results from this study will enable the development of appropriate dosing recommendations in subjects with impaired hepatic function.
Primary Outcome
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
Conditions Studied
Interventions
- DRUG Gepotidacin
Study Locations (2)
Florida
- GSK Investigational Site - Miami
- GSK Investigational Site - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2018-12-26 |
| Phase | Phase 1 |
What the finished NCT03562117 record still lists
NCT03562117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Infections, Bacterial appearing as the primary indexed condition, and to 1 intervention - of which Gepotidacin is the first listed.
NCT03562117 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03562117 about?
NCT03562117 is a clinical study titled "Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function". This is a two-part study which will evaluate the PK, safety, and tolerability of a single 1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in subjects with mild, moderate, and severe hepatic impairment. In Part 1, subjects with moderate hepatic impairment and...
What is the current status of trial NCT03562117?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2018-06-14. Estimated completion is 2018-12-26.
What conditions does trial NCT03562117 study?
This clinical trial studies the following conditions: Infections, Bacterial.
What interventions are being tested in trial NCT03562117?
The interventions under investigation include: Gepotidacin (DRUG).
Who is sponsoring clinical trial NCT03562117?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03562117 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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