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

NCT03188783

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Healthy Volunteer

Interventions: GDC-0853, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Cypress, California, United States