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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621957
• Other study ID #: GP29825
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2015
• Last updated: November 1, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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).
• Pravastatin
Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax) of Pravastatin		Days 1-3 (Period 1) and Days 7-10 (Period 2)	No
Primary	Time to Maximum Concentration (Tmax) of Pravastatin		Days 1-3 (Period 1) and Days 7-10 (Period 2)	No
Primary	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)	No
Primary	Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Pravastatin		Days 1-3 (Period 1) and Days 7-10 (Period 2)	No
Primary	Apparent Volume of Distribution (Vz/F) of Pravastatin		Days 1-3 (Period 1) and Days 7-10 (Period 2)	No
Primary	Apparent Clearance (CL/F) of Pravastatin		Days 1-3 (Period 1) and Days 7-10 (Period 2)	No
Primary	Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin		Days 1-3 (Period 1) and Days 7-10 (Period 2)	No
Primary	Apparent Terminal Elimination Half-Life (t1/2) of Pravastatin		Days 1-3 (Period 1) and Days 7-10 (Period 2)	No
Primary	Amount of Pravastatin Excreted in Urine (Ae)		Day 1 (Period 1) and Day 7 (Period 2)	No
Primary	Renal Clearance (CLR) of Pravastatin		Day 1 (Period 1) and Day 7 (Period 2)	No
Primary	Percentage of Pravastatin Excreted in Urine (%Excreted)		Day 1 (Period 1) and Day 7 (Period 2)	No
Primary	Plasma Concentrations of Pravastatin		Days 1-3 (Period 1) and Days 7-10 (Period 2)	No
Secondary	Maximum Observed Concentration (Cmax) of GDC-0810		Days 7-10 (Period 2)	No
Secondary	Time to Maximum Concentration (Tmax) of GDC-0810		Days 7-10 (Period 2)	No
Secondary	Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-0810		Days 7-10 (Period 2)	No
Secondary	Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of GDC-0810		Days 7-10 (Period 2)	No
Secondary	Apparent Volume of Distribution (Vz/F) of GDC-0810		Days 7-10 (Period 2)	No
Secondary	Apparent Clearance (CL/F) of GDC-0810		Days 7-10 (Period 2)	No
Secondary	Apparent Terminal Elimination Rate Constant (lambda z) of GDC-0810		Days 7-10 (Period 2)	No
Secondary	Apparent Terminal Elimination Half-Life (t1/2) of GDC-0810		Days 7-10 (Period 2)	No
Secondary	Amount of GDC-0810 Excreted in Urine (Ae)		Day 7 (Period 2)	No
Secondary	Renal Clearance (CLr) of GDC-0810		Day 7 (Period 2)	No
Secondary	Percentage of GDC-0810 Excreted in Urine (%Excreted)		Day 7 (Period 2)	No
Secondary	Percentage of Participants with Adverse Events (AEs)		From baseline to study completion up to Day 28	No
Secondary	Percentage of Participants with Serious Adverse Events (SAEs)		From baseline to study completion up to Day 28	No
Secondary	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	No
Secondary	Plasma Concentrations of GDC-0810		Days 7-10 (Period 2)	No