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NCT01852565 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Effect of Repeated Administration of Diltiazem on the Pharmacokinetics of Darapladib (Sb-480848).
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01852565: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01852565 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01852565, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV) events in patient populations with chronic coronary heart disease and after an acute coronary syndrome. This study will determine the effect of repeated administration of diltiazem on the pharmacokinetics of a repeated administration of darapladib. A drug interaction study with a moderate CYP3A4 inhibitor is warranted to provide guidance to prescribing physicians.
Primary Outcome
The area under the concentrations-time curve (AUC0-24) from the time of administration of darapladib up to 24 h after administration.
Interventions
- DRUG Diltiazem
- DRUG Darapladib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-05-14 |
| Est. Completion | 2013-09-30 |
| Phase | Phase 1 |
What the finished NCT01852565 record still lists
NCT01852565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Diltiazem is the first listed.
NCT01852565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01852565 about?
NCT01852565 is a clinical study titled "Study to Determine the Effect of Repeated Administration of Diltiazem on the Pharmacokinetics of Darapladib (Sb-480848).". Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV) events in patient population...
What is the current status of trial NCT01852565?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-05-14. Estimated completion is 2013-09-30.
What interventions are being tested in trial NCT01852565?
The interventions under investigation include: Diltiazem (DRUG), Darapladib (DRUG).
Who is sponsoring clinical trial NCT01852565?
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 NCT01852565's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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