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NCT01873339 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Interaction of Darapladib and CYP 3A4 in Healthy Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01873339: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01873339 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01873339, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study will determine the effect of single and repeat administration of darapladib, a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development on the pharmacokinetics of a single oral dose of midazolam, a cytochrome P450 3A4 (CYP3A4) probe substrate. This study will investigate the inductive and inhibitory effect of darapladib on CYP3A4 metabolic pathway.
Primary Outcome
The effects of repeat oral dosing of darapladib (160mg enteric coated \[EC\] tablet once daily \[QD\]) on the pharmacokinetic parameters - Cmax and AUC(0-infinity\[inf\]) of a single oral dose of midazolam (5 mg) will be evaluated
Interventions
- DRUG Midazolam
- DRUG Darapladib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-06-19 |
| Est. Completion | 2013-09-12 |
| Phase | Phase 1 |
What the finished NCT01873339 record still lists
NCT01873339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT01873339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01873339 about?
NCT01873339 is a clinical study titled "Pharmacokinetic Interaction of Darapladib and CYP 3A4 in Healthy Subjects". This study will determine the effect of single and repeat administration of darapladib, a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development on the pharmacokinetics of a single oral dose of midazolam, a cytochrome P450 ...
What is the current status of trial NCT01873339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2013-06-19. Estimated completion is 2013-09-12.
What interventions are being tested in trial NCT01873339?
The interventions under investigation include: Midazolam (DRUG), Darapladib (DRUG).
Who is sponsoring clinical trial NCT01873339?
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 NCT01873339's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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