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A PHASE 1, OPEN-LABEL, SINGLE-DOSE, RANDOMIZED, 2-PERIOD, 2-TREATMENT SEQUENCE CROSS-OVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF COBIMETINIB ADMINISTERED AS A TABLET FORMULATION COMPARED TO A CAPSULE FORMULATION IN HEALTHY SUBJECTS
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.
Details
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | 2014-04 |
| Completion | 2014-05 |
Conditions
- Healthy Volunteer
Interventions
- cobimetinib
- cobimetinib
Primary outcomes
- Maximum observed concentration (Cmax) — Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
- Time to maximum concentration (tmax) — Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
- Area under the concentration-time curve (AUC) — Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
- Apparent terminal elimination rate constant — Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
- Half-life (t1/2) — Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
- Apparent clearance (CL/F) — Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Countries
United States