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NCT02136524 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02136524 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 28 participants.
The verdict
NCT02136524, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female participants. A minimum of 24 participants (12 participants per sequence) will complete the study. Participants will be randomly assigned to 2 possible sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One cobimetinib tablet administered as a single oral dose after at least an 8-hour fast; Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an 8-hour fast. The study is expected to last approximately 7 weeks.
Interventions
- DRUG cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02136524
The ClinicalTrials.gov registry entry for NCT02136524 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which cobimetinib is the first listed.
NCT02136524 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02136524 about?
NCT02136524 is a clinical study titled "A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation". This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female partic...
What is the current status of trial NCT02136524?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2014-04. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02136524?
The interventions under investigation include: cobimetinib (DRUG).
Who is sponsoring clinical trial NCT02136524?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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