A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants
NCT03188783 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2019-08-07
Summary
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.
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
GDC-0853
GDC-0853 tablets orally, either a single dose or twice-daily.
- DRUG
-
GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-01-24
- Primary Completion
- 2017-08-09
- Completion
- 2017-08-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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