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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/12/2018
Start Date:January 24, 2017
End Date:August 9, 2017

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A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Subjects

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.

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.

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
We found this trial at
1
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Cypress, California 90630
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Cypress, CA
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