A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT02136524
- Run by
- Genentech, Inc.
- People needed
- 28
- Starts
- 2014-04-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Study site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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