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


Original post, click here

Verified May 2017 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT03188783

First received: June 14, 2017

Last updated: June 14, 2017

Last verified: May 2017

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.

Healthy Volunteer Drug: GDC-0853
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Primary Outcome Measures:

  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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.

  • Number of Participants with Clinical Significant Change in Vital Sign, Physical Examination Findings, Clinical Laboratory Results and Electrocardiograms (ECGs) [ Time Frame: 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.

Secondary Outcome Measures:

  • Maximum Observed Plasma Concentration (Cmax) of GDC-0853 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.

Estimated Enrollment: 32
Actual Study Start Date: January 24, 2017
Estimated Study Completion Date: August 2, 2017
Estimated Primary Completion Date: August 2, 2017 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03188783

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

Hoffmann-La Roche

Study Chair: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03188783     History of Changes
Other Study ID Numbers: GP39851
Study First Received: June 14, 2017
Last Updated: June 14, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on June 15, 2017