A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants

Genentech, Inc.63 enrolled

Overview

The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

GDC-0853DRUG

Participants will receive different formulations of GDC-0853 tablet.

RabeprazoleDRUG

Participants will receive rabeprazole 20 mg twice daily (BID) for three days prior to GDC-0853 administration and a single dose coadministered with GDC-0853.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or female (of non-childbearing potential) participants * Within body mass index range 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive * In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs and physical examinations * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: * History or symptoms of any significant disease * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance * History of stomach or intestinal surgery or resection * Participants who previously participated in any other investigational study drug trial within 90 days prior to Check-in. Participants who previously received GDC-0853 in previous studies. * History of malignancy * Pregnancy, lactation, or breastfeeding in female participants

Locations (1)

Quotient Clinical Ltd, Clinical Research Unit

Nottingham, United Kingdom