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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose | Experimental | Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth. |
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| Cohort 2: GDC-0853 Intermediate Dose | Experimental | 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. |
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| Cohort 3: GDC-0853 Intermediate Dose | Experimental | 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. |
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| Cohort 4: GDC-0853 Low Dose | Experimental | Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0853 | Drug | GDC-0853 tablets orally, either a single dose or twice-daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Cohorts 1 and 4: up to Day 29; Cohorts 2 and 3: up to Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of GDC-0853 | Cmax is the maximum observed plasma concentration. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Cypress | California | 90630 | United States |
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| ID | Term |
|---|---|
| C000619415 | fenebrutinib |
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| Placebo | Drug | GDC-0853 matching placebo tablets orally, either a single dose or twice-daily. |
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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.
| Predose and up to 72 hours postdose |
| 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. | Predose and up to 72 hours postdose |