A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants
- Registration Number
- NCT03290703
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 2: GDC-0853 (Effect of Food and Rabeprazole) Rabeprazole 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. Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole) GDC-0853 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. Part 1: GDC-0853 (Effect of Formulation) GDC-0853 Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state. Part 2: GDC-0853 (Effect of Food and Rabeprazole) GDC-0853 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. Part 1: GDC-0853 (Effect of Formulation) Rabeprazole Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state. Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole) Rabeprazole 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.
- Primary Outcome Measures
Name Time Method Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Maximum Observed Plasma Concentration (Cmax) of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Relative Bioavailability (Frel) of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Area Under the Curve From Time Zero to Last Measurable Concentration [AUC (0-t)] of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Apparent Volume of Distribution (Vz/F) of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Apparent Terminal Elimination Half-Life (t1/2) of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Apparent Terminal Elimination Rate Constant of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part Apparent Oral Clearance (CL/F) of GDC-0853 Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) From screening to the end of the study (approximately a maximum of 11 weeks)
Trial Locations
- Locations (1)
Quotient Clinical Ltd, Clinical Research Unit
🇬🇧Nottingham, United Kingdom