A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136524
• Other study ID #: GP28370
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2014
• Last updated: November 1, 2016
• Start date: April 2014
• Est. completion date: May 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• cobimetinib
Single, oral dose given as a tablet on Day 1 after a minimum 8 h fast
• cobimetinib
Single, oral dose given as 4 capsules on Day 1 after a minimum 8 h fast

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)	No
Primary	Time to maximum concentration (tmax)		Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)	No
Primary	Area under the concentration-time curve (AUC)		Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)	No
Primary	Apparent terminal elimination rate constant		Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)	No
Primary	Half-life (t1/2)		Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)	No
Primary	Apparent clearance (CL/F)		Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)	No
Primary	Apparent volume of distribution (Vz/F)		Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)	No
Primary	Relative bioavailability (Frel)		Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)	No
Secondary	Incidence of adverse events		Up to 4 weeks	No