A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian 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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-24

Study Completion Date

2017-08-09

Brief Summary

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The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of GDC-0853 in healthy Japanese and Caucasian subjects.

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Detailed Description

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This study will be a randomized, placebo-controlled, double-blind, single and multiple dose study. Approximately 32 healthy subjects will be enrolled in 4 discrete cohorts with 8 subjects per cohort.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1: GDC-0853 Low Dose

Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.

Group Type EXPERIMENTAL

GDC-0853

Intervention Type DRUG

GDC-0853 tablets orally, either a single dose or twice-daily.

Placebo

Intervention Type DRUG

GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.

Cohort 2: GDC-0853 Intermediate Dose

Japanese subjects will receive a single intermediate dose of GDC-0853 or matching placebo by mouth. Subsequently, participants will receive twice-daily intermediate doses of GDC-0853 or matching placebo by mouth for 4 days followed by a single intermediate dose of GDC-0853 or matching placebo by mouth.

Group Type EXPERIMENTAL

GDC-0853

Intervention Type DRUG

GDC-0853 tablets orally, either a single dose or twice-daily.

Placebo

Intervention Type DRUG

GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.

Cohort 3: GDC-0853 Intermediate Dose

Caucasian subjects will receive a single intermediate dose of GDC-0853 or matching placebo by mouth. Subsequently, participants will receive twice-daily intermediate doses of GDC-0853 or matching placebo by mouth for 4 days followed by a single intermediate dose of GDC-0853 or matching placebo by mouth.

Group Type EXPERIMENTAL

GDC-0853

Intervention Type DRUG

GDC-0853 tablets orally, either a single dose or twice-daily.

Placebo

Intervention Type DRUG

GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.

Cohort 4: GDC-0853 Low Dose

Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.

Group Type EXPERIMENTAL

GDC-0853

Intervention Type DRUG

GDC-0853 tablets orally, either a single dose or twice-daily.

Placebo

Intervention Type DRUG

GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.

Interventions

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GDC-0853

GDC-0853 tablets orally, either a single dose or twice-daily.

Intervention Type DRUG

Placebo

GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese subjects must have both Japanese parents and all grandparents who were born in a Japanese country of origin
* Caucasian subjects must have 4 Caucasian grandparents (Hispanics of white race can be considered Caucasians)
* Within body mass index range of 18 to 31 kilograms per square meter, inclusive
* Females will be non-pregnant, non-lactating, and either postmenopausal or surgically sterile
* Males will either be sterile or agree to use an approved method of contraception

Exclusion Criteria

* Significant history or clinical manifestation of any significant metabolic, allergic/immunologic/immunodeficiency, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Participation in any other investigational study drug trial in which receipt of any investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check in
* History of malignancy, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 3-year disease-free follow up
* Any acute or chronic condition or any other reason that, in the opinion of the investigator, would limit the participant's ability to complete and/or participate in this clinical study

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes