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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: GDC-0853; Drug: Rabeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03290703

2017-000752-26 (EudraCT Number)

GP39619

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Part 1: GDC-0853 (Effect of Formulation)

Experimental group

Description:

Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.

Treatment:

Drug: Rabeprazole

Drug: GDC-0853

Part 2: GDC-0853 (Effect of Food and Rabeprazole)

Experimental group

Description:

Participants will receive three single oral doses of one GDC-0853 formulations selected from Part 1 of this study. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.

Treatment:

Drug: Rabeprazole

Drug: GDC-0853

Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)

Experimental group

Description:

Participants will receive three single oral doses of an optimized tablet formulations of GDC-0853. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.

Treatment:

Drug: Rabeprazole

Drug: GDC-0853