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NCT01489943 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01489943 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 24 participants.
The verdict
NCT01489943, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to test the effects of study drug (GSK1605786) on the blood levels of multiple commonly used drugs that are given to measure how your liver breaks down the study drug. These commonly-used drugs are midazolam, pioglitazone, omeprazole, and rosuvastatin which will determine the effect of GSK1605786 on how the body breaks down (metabolizes) these commonly-used drugs. Blood samples for pharmacokinetic analysis of GSK1605786, and two metabolites, \[GSK2635622 (CCX062) and GSK2656694 (CCX304)\] and four probe substrates will be collected over a 24-hour period after administration. Safety will be assessed by the measurement of vital signs, cardiac monitoring, collection of adverse event assessments and laboratory tests.
Interventions
- DRUG GSK1605786 500 mg
- DRUG Midazolam 3 mg
- DRUG Pioglitazone 15 mg
- DRUG Omeprazole 40 mg
- DRUG Rosuvastatin 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-09-19 |
| Est. Completion | 2011-11-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01489943
The ClinicalTrials.gov registry entry for NCT01489943 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 5 interventions - of which GSK1605786 500 mg is the first listed.
NCT01489943 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01489943 about?
NCT01489943 is a clinical study titled "A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects". The purpose of this study is to test the effects of study drug (GSK1605786) on the blood levels of multiple commonly used drugs that are given to measure how your liver breaks down the study drug. These commonly-used drugs are midazolam, pioglitazone, omeprazole, and rosuvastatin which will determin...
What is the current status of trial NCT01489943?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-09-19. Estimated completion is 2011-11-10.
What interventions are being tested in trial NCT01489943?
The interventions under investigation include: GSK1605786 500 mg (DRUG), Midazolam 3 mg (DRUG), Pioglitazone 15 mg (DRUG), Omeprazole 40 mg (DRUG), Rosuvastatin 10 mg (DRUG).
Who is sponsoring clinical trial NCT01489943?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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