CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Cobimetinib +1 moredrug
Likely dose
Cobimetinib 240 mLfrom 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/NCT01277718
NCT01277718Phase 1Completed
CompareCT.gov

A Phase 1, Open-Label, 3-Period, Randomized, Crossover Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of GDC-0973 in Healthy Subjects

Genentech, Inc.·interventional·Posted Jan 17, 2011·Updated May 10, 2017

In Brief

A Phase 1 clinical trial evaluating Cobimetinib and Rabeprazole for Healthy Volunteer. Completed, enrolled 20 participants.

Detailed Summary

This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of cobimetinib in healthy participants to evaluate the effect of the proton-pump inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy participants when administered in the fed or fasted states.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 17, 2011
Enrollment StartJan 1, 2011
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.5 years ago

Interventions

Cobimetinibdrug

One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal.

Rabeprazoledrug

Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.