A Phase 1, Open-Label Study to Evaluate the Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Pravastatin
研究概览
简要总结
This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and without concomitant GDC-0810 administration in healthy female subjects of non-childbearing potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be determined in the presence of GDC-0810.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects between 18 and 65 years of age, inclusive.
- •Female subjects of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure.
- •Within BMI range 18.5 to </= 29.9 kg/m^2, inclusive.
- •In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.
- •Receive an explanation of the mandatory pharmacogenomic (PgX) component of the study.
排除标准
- •Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.
- •Previous history of adverse reaction to statins.
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1) in Period
- •Use of systemic hormone replacement therapy within 1 year prior to Check-in (Day -1).
- •History of use of tamoxifen, aromatase inhibitor or any other endocrine agent for treatment of breast cancer.
- •Female subject is pregnant lactating, or breast feeding.
研究组 & 干预措施
Female Healthy Volunteers
Healthy volunteer female subjects of non-childbearing potential will be administered pravastatin once on Day 1 during Period 1 (Day -1 to Day 4). During Period 2 (Days 5-28) GDC-0810 will be administered daily on Days 5-8. Pravastatin will be co-administered on Day 7.
干预措施: GDC-0810 (Drug)
Female Healthy Volunteers
Healthy volunteer female subjects of non-childbearing potential will be administered pravastatin once on Day 1 during Period 1 (Day -1 to Day 4). During Period 2 (Days 5-28) GDC-0810 will be administered daily on Days 5-8. Pravastatin will be co-administered on Day 7.
干预措施: Pravastatin (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Maximum Observed Concentration (Cmax) of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Time to Maximum Concentration (Tmax) of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Apparent Volume of Distribution (Vz/F) of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Amount of Pravastatin Excreted in Urine (Ae)
时间窗: Day 1 (Period 1) and Day 7 (Period 2)
Apparent Clearance (CL/F) of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Apparent Terminal Elimination Half-Life (t1/2) of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Renal Clearance (CLR) of Pravastatin
时间窗: Day 1 (Period 1) and Day 7 (Period 2)
Percentage of Pravastatin Excreted in Urine (%Excreted)
时间窗: Day 1 (Period 1) and Day 7 (Period 2)
Plasma Concentrations of Pravastatin
时间窗: Days 1-3 (Period 1) and Days 7-10 (Period 2)
次要结局
- Time to Maximum Concentration (Tmax) of GDC-0810(Days 7-10 (Period 2))
- Maximum Observed Concentration (Cmax) of GDC-0810(Days 7-10 (Period 2))
- Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-0810(Days 7-10 (Period 2))
- Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of GDC-0810(Days 7-10 (Period 2))
- Apparent Volume of Distribution (Vz/F) of GDC-0810(Days 7-10 (Period 2))
- Apparent Clearance (CL/F) of GDC-0810(Days 7-10 (Period 2))
- Apparent Terminal Elimination Rate Constant (lambda z) of GDC-0810(Days 7-10 (Period 2))
- Apparent Terminal Elimination Half-Life (t1/2) of GDC-0810(Days 7-10 (Period 2))
- Amount of GDC-0810 Excreted in Urine (Ae)(Day 7 (Period 2))
- Renal Clearance (CLr) of GDC-0810(Day 7 (Period 2))
- Percentage of GDC-0810 Excreted in Urine (%Excreted)(Day 7 (Period 2))
- Percentage of Participants with Adverse Events (AEs)(From baseline to study completion up to Day 28)
- Percentage of Participants with Serious Adverse Events (SAEs)(From baseline to study completion up to Day 28)
- Percentage of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Electrocardiograms (ECGs), Physical Examination Findings and Clinical Laboratory Results.(From baseline to study completion up to Day 28)
- Plasma Concentrations of GDC-0810(Days 7-10 (Period 2))