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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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01489943 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Midazolam AUC(0-infinity) following oral administration of midazolam alone (Day 1) and in combination with GSK1605786 (Day 11).Pioglitazone AUC(0-infinity) following oral administration of pioglitazone alone (Day 2) and in combination with GSK1605786 (Day 12).Omeprazole and 5-hydroxyomeprazole AUC(0-infinity) following oral administration of omeprazole alone (Day 3) and in combination with GSK1605786 (Day 13).
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 |
What the finished NCT01489943 record still lists
NCT01489943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which GSK1605786 500 mg is the first listed.
NCT01489943 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01489943's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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