Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
- Registration Number
- NCT02621957
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 1.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Female Healthy Volunteers Pravastatin 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. Female Healthy Volunteers GDC-0810 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.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2) Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2) Maximum Observed Concentration (Cmax) of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2) Time to Maximum Concentration (Tmax) of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2) Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2) Apparent Volume of Distribution (Vz/F) of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2) Amount of Pravastatin Excreted in Urine (Ae) Day 1 (Period 1) and Day 7 (Period 2) Apparent Clearance (CL/F) of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2) Apparent Terminal Elimination Half-Life (t1/2) of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2) Renal Clearance (CLR) of Pravastatin Day 1 (Period 1) and Day 7 (Period 2) Percentage of Pravastatin Excreted in Urine (%Excreted) Day 1 (Period 1) and Day 7 (Period 2) Plasma Concentrations of Pravastatin Days 1-3 (Period 1) and Days 7-10 (Period 2)
- Secondary Outcome Measures
Name Time Method 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)