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NCT02371603 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT02371603: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02371603 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02371603, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
This study will be a two-part with an open-label, single oral dose, two-way crossover study design. Part A and Part B of the study are independent and may be conducted in parallel. The Part A of the study will assess the effect of an oral dose of GSK1278863 on the pharmacokinetics of a CYP2C8 (pioglitazone) and OATP1B1 (rosuvastatin) probe substrate in order to determine the potential for clinically-significant drug interactions with CYP2C8 and OATP1B1 substrates. The Part B of the study will assess the effect of a weak CYP2C8 inhibitor (trimethoprim) on the pharmacokinetics of GSK1278863 and its six predominant metabolites. Part A will be conducted in approximately 30 healthy subjects, having a randomized study design. There will be approximate 7-day washout period between each dosing period. Part B will be conducted in approximately 20 healthy subjects, having single sequence study design. Follow up will be conducted within 7 to 10 days after the last dose in both Part A and B. The total duration of a subject's involvement in the part A of the study will be approximately 8 weeks (Screening to Follow-up) and in part B will be approximately 7 weeks (Screening to Follow-up).
Primary Outcome
The effect of an oral dose of GSK1278863 on the pharmacokinetics of pioglitazone will be assessed using the following PK parameters: maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC (0-infinity)
Interventions
- DRUG GSK1278863 25 mg Tablet
- DRUG Pioglitazone 15 mg Tablet
- DRUG Rosuvastatin 10 mg Tablet
- DRUG Trimethoprim 100 mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2015-02-11 |
| Est. Completion | 2015-08-12 |
| Phase | Phase 1 |
What the finished NCT02371603 record still lists
NCT02371603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 4 interventions - of which GSK1278863 25 mg Tablet is the first listed.
NCT02371603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02371603 about?
NCT02371603 is a clinical study titled "Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers". This study will be a two-part with an open-label, single oral dose, two-way crossover study design. Part A and Part B of the study are independent and may be conducted in parallel. The Part A of the study will assess the effect of an oral dose of GSK1278863 on the pharmacokinetics of a CYP2C8 (piogl...
What is the current status of trial NCT02371603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2015-02-11. Estimated completion is 2015-08-12.
What interventions are being tested in trial NCT02371603?
The interventions under investigation include: GSK1278863 25 mg Tablet (DRUG), Pioglitazone 15 mg Tablet (DRUG), Rosuvastatin 10 mg Tablet (DRUG), Trimethoprim 100 mg Tablet (DRUG).
Who is sponsoring clinical trial NCT02371603?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02371603's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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