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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: GDC-0853
* Drug: Rabeprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: GDC-0853 (Effect of Formulation)<br>Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state. | Drug: GDC-0853<br>* Participants will receive different formulations of GDC-0853 tablet.<br>* Other names: RO7010939;Drug: Rabeprazole<br>* 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.<br>|
| Experimental: Part 2: GDC-0853 (Effect of Food and Rabeprazole)<br>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<br>* Participants will receive different formulations of GDC-0853 tablet.<br>* Other names: RO7010939;Drug: Rabeprazole<br>* 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.<br>|
| Experimental: Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)<br>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<br>* Participants will receive different formulations of GDC-0853 tablet.<br>* Other names: RO7010939;Drug: Rabeprazole<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) |  | From screening to the end of the study (approximately a maximum of 11 weeks) |