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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 70 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02371603
The ClinicalTrials.gov registry entry for NCT02371603 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 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 4 interventions - of which GSK1278863 25 mg Tablet is the first listed.
NCT02371603 reports 0 study locations.
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.
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