Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Pravastatin

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.

• 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.