CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
cobimetinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02300025
NCT02300025Phase 1Completed
CompareCT.gov

A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage

Genentech, Inc.·interventional·Posted Nov 24, 2014·Updated Feb 19, 2016

In Brief

A Phase 1 clinical trial evaluating cobimetinib for Healthy Volunteer. Completed, enrolled 28 participants across 3 sites.

Detailed Summary

This study is an open-label, multi-center, single-dose, parallel group study to determine the pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted male and female adult subjects with varying degrees of hepatic function. The study will be conducted based on the Child-Pugh classification of hepatic impairment. The anticipated duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying degrees of hepatic function and up to 12 healthy control volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 24, 2014
Enrollment StartAug 1, 2014
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.6 years ago

Interventions

cobimetinibdrug

single oral 10-mg dose of cobimetinib