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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants with Clinical Significant Change in Vital Sign, Physical Examination Findings, Clinical Laboratory Results and Electrocardiograms (ECGs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 1: GDC-0853 Low Dose
Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.
干预措施: GDC-0853 (Drug)
Cohort 1: GDC-0853 Low Dose
Japanese subjects will receive a single low dose of GDC-0853 or matching placebo by mouth.
干预措施: Placebo (Drug)
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.
干预措施: GDC-0853 (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: GDC-0853 (Drug)
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.
干预措施: Placebo (Drug)
Cohort 4: GDC-0853 Low Dose
Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.
干预措施: GDC-0853 (Drug)
Cohort 4: GDC-0853 Low Dose
Japanese subjects will receive a single high dose of GDC-0853 or matching placebo by mouth.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Clinical Significant Change in Vital Sign, Physical Examination Findings, Clinical Laboratory Results and Electrocardiograms (ECGs)
时间窗: 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.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 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.
次要结局
- Maximum Observed Plasma Concentration (Cmax) of GDC-0853(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(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)(Predose and up to 72 hours postdose)