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 |
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.
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.
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
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