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

• Status: Completed
• Trial end date: 2017-12-14
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: Quotient Clinical
• Treatments: Proton Pump Inhibitors; Rabeprazole

Criteria

Inclusion Criteria:

• Healthy female participants between 30 and 65 years of age, inclusive;

• Within body mass index range 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive;

• Female participants will be of non-childbearing potential;

• In good health, determined by no clinically significant findings from medical history, 12-lead echocardiogram (ECG), and vital signs;

• Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the investigator;

• Normal ophthalmology assessment.

Exclusion Criteria:

• Males and females of childbearing potential;

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator;

• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator;

• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs;

• History of GI bleeding or GI ulcers;

• Any personal or family history of bleeding disorders, and any personal use of drugs known to affect blood clotting within 30 days of dosing;

• Any acute or chronic medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the subject's safe participation in and completion of the study.