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NCT02625207 · ClinicalTrials.gov registry record · Phase 1
THE Effect OF Cyp3a5 Genotype ON THE Pharmacokinetics OF Maraviroc
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT02625207: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT02625207 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02625207, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians in subjects carrying two copies of the dysfunctional CYP3A5 alleles (\*3, \*6, and/or \*7).
Primary Outcome
AUC (0-12) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose.
Interventions
- DRUG Maraviroc (Part 1)
- DRUG Maraviroc (Part 2)
- DRUG Darunavir/cobicistat (Part 2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-11-06 |
| Est. Completion | 2016-03-26 |
| Phase | Phase 1 |
What the finished NCT02625207 record still lists
NCT02625207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 3 interventions - of which Maraviroc (Part 1) is the first listed.
NCT02625207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02625207 about?
NCT02625207 is a clinical study titled "THE Effect OF Cyp3a5 Genotype ON THE Pharmacokinetics OF Maraviroc". This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and CYP3A5-derived metabolite P...
What is the current status of trial NCT02625207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2015-11-06. Estimated completion is 2016-03-26.
What interventions are being tested in trial NCT02625207?
The interventions under investigation include: Maraviroc (Part 1) (DRUG), Maraviroc (Part 2) (DRUG), Darunavir/cobicistat (Part 2) (DRUG).
Who is sponsoring clinical trial NCT02625207?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02625207's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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