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

NCT03188783 | Completed Phase 1 FDA Drug

• 1 other identifier: GP39851
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of GDC-0853

  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

  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)

  Predose and up to 72 hours postdose

Study Arms (4)

Cohort 1: GDC-0853 Low Dose

EXPERIMENTAL

Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.

Drug: GDC-0853; Drug: Placebo

Cohort 2: GDC-0853 Intermediate Dose

EXPERIMENTAL

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; Drug: Placebo

Cohort 3: GDC-0853 Intermediate Dose

EXPERIMENTAL

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; Drug: Placebo

Cohort 4: GDC-0853 Low Dose

EXPERIMENTAL

Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.

Drug: GDC-0853; Drug: Placebo

Interventions

GDC-0853 DRUG

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

Cohort 1: GDC-0853 Low Dose; Cohort 2: GDC-0853 Intermediate Dose; Cohort 3: GDC-0853 Intermediate Dose; Cohort 4: GDC-0853 Low Dose

Placebo DRUG

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

Cohort 1: GDC-0853 Low Dose; Cohort 2: GDC-0853 Intermediate Dose; Cohort 3: GDC-0853 Intermediate Dose; Cohort 4: GDC-0853 Low Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

fenebrutinib

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 15, 2017
• Study Start: January 24, 2017
• Primary Completion: August 9, 2017
• Study Completion: August 9, 2017
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (1)