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

Genentech

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: GDC-0810; Drug: Pravastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02621957

GP29825

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Female Healthy Volunteers

Experimental group

Description:

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.

Treatment:

Drug: Pravastatin

Drug: GDC-0810