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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
West Coast Clinical Trials
Cypress, California, United States
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.
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)
Number of participants with clinical significant change in vital sign, physical examination findings, clinical laboratory results and electrocardiograms (ECGs) will be reported.
Time frame: Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36
Maximum Observed Plasma Concentration (Cmax) of GDC-0853
Cmax is the maximum observed plasma concentration.
Time frame: 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.
Time frame: Predose and up to 72 hours postdose
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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.
Time frame: Predose and up to 72 hours postdose