Healthy Volunteer
Conditions
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.
Interventions
DRUGGDC-0853
GDC-0853 tablets orally, either a single dose or twice-daily.
DRUGPlacebo
GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of GDC-0853 | 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 | 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) | 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. |
Countries
United States
Outcome results
None listed