Healthy Volunteers
Conditions
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.
Interventions
DRUGGDC-0853
Participants will receive different formulations of GDC-0853 tablet.
DRUGRabeprazole
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.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | From screening to the end of the study (approximately a maximum of 11 weeks) |
Countries
United Kingdom
Outcome results
None listed