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Completed

NCT Number: NCT02136524

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

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cobimetinib

Drug

Single, oral dose given as a tablet on Day 1 after a minimum 8 h fast

Other names: GDC-0973, XL-518

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)

  2. Time to maximum concentration (tmax)

    Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)

  3. Area under the concentration-time curve (AUC)

    Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)

  4. Apparent terminal elimination rate constant

    Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)

  5. Half-life (t1/2)

    Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)

  6. Apparent clearance (CL/F)

    Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)

  7. Apparent volume of distribution (Vz/F)

    Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)

  8. Relative bioavailability (Frel)

    Time frame: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to 4 weeks

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 13, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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