A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants
Status and phase
Completed
Phase 1
Conditions
Healthy Volunteer
Treatments
Drug: GDC-0853
Drug: Placebo
Details and patient eligibility
About
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.
Full description
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.
Enrollment
32 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
32 participants in 4 patient groups
Cohort 1: GDC-0853 Low Dose
Experimental group
Description:
Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.
Treatment:
Drug: Placebo
Drug: GDC-0853
Cohort 2: GDC-0853 Intermediate Dose
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: GDC-0853
Cohort 3: GDC-0853 Intermediate Dose
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: GDC-0853
Cohort 4: GDC-0853 Low Dose
Experimental group
Description:
Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.
Treatment:
Drug: Placebo
Drug: GDC-0853
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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