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NCT01772290 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib
A Phase 1 study of Healthy Volunteer, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
- 2
- Study locations
NCT01772290: Completed Phase 1 study of Healthy Volunteer, sponsored by Genentech.
NCT01772290 is a Phase 1 study of Healthy Volunteer that has completed, run by Genentech. The registered enrollment target is 92 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01772290, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
- 2
- Study locations
Study Summary
This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of non-childbearing potential. Subjects will be randomized to receive multiple oral doses of vismodegib, alone or in combination with multiple oral doses of either rabeprazole, itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.
Conditions Studied
Interventions
- DRUG itraconazole
- DRUG fluconazole
- DRUG rabeprazole
- DRUG vismodegib
Study Locations (2)
Florida
- - Daytona Beach
Texas
- - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01772290 record still lists
NCT01772290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions - of which itraconazole is the first listed.
NCT01772290 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT01772290 about?
NCT01772290 is a clinical study titled "A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib". This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of non-childbearing potential. Subje...
What is the current status of trial NCT01772290?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2013-02. Estimated completion is 2013-05.
What conditions does trial NCT01772290 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01772290?
The interventions under investigation include: itraconazole (DRUG), fluconazole (DRUG), rabeprazole (DRUG), vismodegib (DRUG).
Who is sponsoring clinical trial NCT01772290?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01772290 being conducted?
This trial has 2 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01772290's enrollment target sits among peer trials
92 38th of 112 higher than 75 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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.
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