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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 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 47 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02625207
The ClinicalTrials.gov registry entry for NCT02625207 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Maraviroc (Part 1) is the first listed.
NCT02625207 reports 0 study locations.
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.
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