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Trial record 3 of 11 for:    GDC-0853

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

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ClinicalTrials.gov Identifier: NCT03188783
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: GDC-0853 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : January 24, 2017
Actual Primary Completion Date : August 9, 2017
Actual Study Completion Date : August 9, 2017

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.




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Maximum Observed Plasma Concentration (Cmax) of GDC-0853 [ Time Frame: Predose and up to 72 hours postdose ]
    Cmax is the maximum observed plasma concentration.

  2. 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.

  3. 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.



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188783


Locations
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United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03188783     History of Changes
Other Study ID Numbers: GP39851
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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