A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/3/2016 |
| Start Date: | April 2014 |
| End Date: | May 2014 |
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.
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.
Inclusion Criteria:
- Healthy male and female volunteers between 18 and 55 years of age, inclusive
- Body mass index between 18.5 to 32.0 kg/m2, inclusive;
- Adequate renal, liver, and hematologic function
- Participants who are in good health as determined by no clinically significant
findings from medical history, 12-lead ECG, vital signs, and clinical laboratory
evaluations
Exclusion Criteria:
- Significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, or psychiatric disorder (as determined by the
Investigator)
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