drugset / Trial / NCT03237741

Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants

NCT03237741

Phase 1 Completed 18 enrolled Genentech, Inc. Quotient Clinical · collab
RandomizedCrossoverOpen-labelTreatment

Summary

This study will evaluate the pharmacokinetics and safety of GDC-0134 in healthy female volunteers of non-childbearing potential. The first part of the study will compare the bioavailability of a prototype capsule of GDC-0134 relative to an existing GDC-0134 reference capsule (Periods 1 and 2). The second part of the study will assess the effect of GDC-0134-in-applesauce preparation under fasting conditions, the effect of low and high fat foods as well as the effect of elevated stomach pH via pre-treatment with rabeprazole, a proton pump inhibitor (PPI), under fasted and high-fat meal conditions (Periods 3 and 4).

Timeline

Start
2017-08-07
Primary completion
2017-12-14
Completion
2017-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject GDC-0134 Small molecule 200 mg Oral
Background Rabeprazole Small molecule 20 mg Oral