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

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Roche

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: GDC-0853
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03188783
GP39851

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

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Data sourced from clinicaltrials.gov

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