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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT03188783

Run by

Hoffmann-La Roche

People needed

32

Starts

2017-01-24

Expected to finish

2017-08-09

Last updated by the study team

2019-08-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• West Coast Clinical Trials — Cypress, California, United States

Full record on ClinicalTrials.gov

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