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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 26 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01873339
The ClinicalTrials.gov registry entry for NCT01873339 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 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 2 interventions - of which Midazolam is the first listed.
NCT01873339 reports 0 study locations.
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.
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