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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsule formulation | Experimental |
| |
| Tablet formulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cobimetinib | Drug | Single, oral dose given as a tablet on Day 1 after a minimum 8 h fast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Apparent volume of distribution (Vz/F) | Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence) | |
| Relative bioavailability (Frel) | Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas | Texas | 75247 | United States |
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| cobimetinib | Drug | Single, oral dose given as 4 capsules on Day 1 after a minimum 8 h fast |
|
|
| ID | Term |
|---|---|
| C574276 | cobimetinib |
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