Clinical trial NCT02136524: A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
measure: Time to maximum concentration (tmax)
timeFrame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
measure: Area under the concentration-time curve (AUC)
timeFrame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
measure: Apparent terminal elimination rate constant
timeFrame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
measure: Half-life (t1/2)
timeFrame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
measure: Apparent clearance (CL/F)
timeFrame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
measure: Apparent volume of distribution (Vz/F)
timeFrame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
measure: Relative bioavailability (Frel)
timeFrame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: