Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2016 |
| Start Date: | December 2015 |
| End Date: | February 2016 |
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
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.
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.
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
- 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.
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