Breast Cancer
Conditions
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.
Interventions
DRUGGDC-0810
During Period 2 subjects will be administered an oral 600 mg dose GDC-0810 daily beginning on Day 5 for 4 consecutive days (from Days 5 to 8, inclusive).
DRUGPravastatin
Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Maximum Concentration (Tmax) 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) |
| 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) |
| Apparent Volume of Distribution (Vz/F) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) |
| Apparent Clearance (CL/F) 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 Terminal Elimination Half-Life (t1/2) 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) |
| 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
| Measure | Time frame |
|---|---|
| Percentage of Participants with Serious Adverse Events (SAEs) | From baseline to study completion up to Day 28 |
| Renal Clearance (CLr) of GDC-0810 | Day 7 (Period 2) |
| Plasma Concentrations of GDC-0810 | Days 7-10 (Period 2) |
| 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 |
| Maximum Observed Concentration (Cmax) of GDC-0810 | Days 7-10 (Period 2) |
| Time to Maximum Concentration (Tmax) 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) |
| 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 |
Countries
United States
Outcome results
None listed