A Phase 1 interventional study of GDC-0853 and Rabeprazole in Healthy Volunteers, sponsored by Genentech, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.
Drug: GDC-0853 · Drug: 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.
Drug: GDC-0853 · Drug: 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.
Drug: GDC-0853 · Drug: Rabeprazole
Participants will receive different formulations of GDC-0853 tablet.
Also known as: RO7010939
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.
Maximum Observed Plasma Concentration (Cmax) of GDC-0853
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Percentage of Participants With Adverse Events (AEs)
Time frame: From screening to the end of the study (approximately a maximum of 11 weeks)
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.