Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: GDC-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).
Other Names:
Drug: Pravastatin
Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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)]
- 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 Outcome Measures
- 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)]
- 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)]
Eligibility Criteria
Criteria
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.
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Within BMI range 18.5 to </= 29.9 kg/m^2, inclusive.
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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.
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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.
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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.
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Use of systemic hormone replacement therapy within 1 year prior to Check-in (Day -1).
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History of use of tamoxifen, aromatase inhibitor or any other endocrine agent for treatment of breast cancer.
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Female subject is pregnant lactating, or breast feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Daytona Beach | Florida | United States | 32117 |
Sponsors and Collaborators
- Genentech, Inc.
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GP29825