Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 14, 2017
First Posted Date  ICMJE June 15, 2017
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE January 24, 2017
Actual Primary Completion Date August 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03188783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Cohort 1: GDC-0853 Low Dose
    Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.
    Interventions:
    • Drug: GDC-0853
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: GDC-0853
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: GDC-0853
    • Drug: Placebo
  • Experimental: Cohort 4: GDC-0853 Low Dose
    Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.
    Interventions:
    • Drug: GDC-0853
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 9, 2017
Actual Primary Completion Date August 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03188783
Other Study ID Numbers  ICMJE GP39851
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP