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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2018-10-25

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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: GDC-0853 (Effect of Formulation)

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

Group Type EXPERIMENTAL

GDC-0853

Intervention Type DRUG

Participants will receive different formulations of GDC-0853 tablet.

Rabeprazole

Intervention Type DRUG

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.

Part 2: GDC-0853 (Effect of Food and 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.

Group Type EXPERIMENTAL

GDC-0853

Intervention Type DRUG

Participants will receive different formulations of GDC-0853 tablet.

Rabeprazole

Intervention Type DRUG

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.

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

Group Type EXPERIMENTAL

GDC-0853

Intervention Type DRUG

Participants will receive different formulations of GDC-0853 tablet.

Rabeprazole

Intervention Type DRUG

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.

Interventions

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GDC-0853

Participants will receive different formulations of GDC-0853 tablet.

Intervention Type DRUG

Rabeprazole

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.

Intervention Type DRUG

Other Intervention Names

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RO7010939

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes