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NCT02853435 · ClinicalTrials.gov registry record · Phase 1
To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02853435 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 48 participants.
The verdict
NCT02853435, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted \[RC\] and high shear wet granulation \[HSWG\]) compared to the reference capsule formulation under fasted conditions. This is a 3-period; cross-over study that will guide which gepotidacin formulation will be used for future studies. Following review of pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed with Parts 1b and 2. Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will be evaluated under fasted conditions. The duration of the study (from Screening to the Follow-up visit) will be approximately 44 days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3 treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12 Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.
Interventions
- DRUG Gepotidacin RC Tablet
- DRUG Gepotidacin HSWG Tablet
- DRUG Gepotidacin Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2016-08-04 |
| Est. Completion | 2017-10-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02853435
The ClinicalTrials.gov registry entry for NCT02853435 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 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 3 interventions - of which Gepotidacin RC Tablet is the first listed.
NCT02853435 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02853435 about?
NCT02853435 is a clinical study titled "To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.". This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted \[RC\] and high shear wet granulation \[HSWG\]) compared to the reference capsule formulation under fasted conditio...
What is the current status of trial NCT02853435?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2016-08-04. Estimated completion is 2017-10-17.
What interventions are being tested in trial NCT02853435?
The interventions under investigation include: Gepotidacin RC Tablet (DRUG), Gepotidacin HSWG Tablet (DRUG), Gepotidacin Capsule (DRUG).
Who is sponsoring clinical trial NCT02853435?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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