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

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: GDC-0853; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • West Coast Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: GDC-0853 Low Dose; Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.	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.
Experimental: Cohort 2: GDC-0853 Intermediate Dose; 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.	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.
Experimental: Cohort 3: GDC-0853 Intermediate Dose; 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.	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.
Experimental: Cohort 4: GDC-0853 Low Dose; Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	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)	Number of participants with clinical significant change in vital sign, physical examination findings, clinical laboratory results and electrocardiograms (ECGs) will be reported.	Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of GDC-0853	Cmax is the maximum observed plasma concentration.	Predose and up to 72 hours postdose
Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of GDC-0853	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.	Predose and up to 72 hours postdose
Area under the plasma concentration-time curve from time zero to time tau over the dosing interval (AUC0-tau)	Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.	Predose and up to 72 hours postdose

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2017
• Primary Completion (Actual): August 9, 2017
• Study Completion (Actual): August 9, 2017

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: GP39851

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No