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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: GDC-0853; Drug: Placebo

• Registration Number: NCT03188783
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-24
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-15
• Primary Completion: 2017-08-09
• Study Completion: 2017-08-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4: GDC-0853 Low Dose	GDC-0853	Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.
Cohort 1: GDC-0853 Low Dose	GDC-0853	Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.
Cohort 1: GDC-0853 Low Dose	Placebo	Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.
Cohort 2: GDC-0853 Intermediate Dose	Placebo	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.
Cohort 2: GDC-0853 Intermediate Dose	GDC-0853	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.
Cohort 3: GDC-0853 Intermediate Dose	GDC-0853	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.
Cohort 3: GDC-0853 Intermediate Dose	Placebo	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.
Cohort 4: GDC-0853 Low Dose	Placebo	Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Clinical Significant Change in Vital Sign, Physical Examination Findings, Clinical Laboratory Results and Electrocardiograms (ECGs)	Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36	Number of participants with clinical significant change in vital sign, physical examination findings, clinical laboratory results and electrocardiograms (ECGs) will be reported.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36	An AE is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as adverse events. A SAE is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe.

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of GDC-0853	Predose and up to 72 hours postdose	Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of GDC-0853	Predose and up to 72 hours postdose	Area under the concentration-time curve from Hour 0 to 48 hours postdose, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations.
Area under the plasma concentration-time curve from time zero to time tau over the dosing interval (AUC0-tau)	Predose and up to 72 hours postdose	Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.

Trial Locations

Locations (1)

West Coast Clinical Trials; 🇺🇸 Cypress, California, United States