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

No results posted yet for this study

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

Placebo

GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.

Sponsors & Collaborators

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03188783 on ClinicalTrials.gov