Clinical trial NCT02621957: Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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 \</= 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.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
measure: Time to Maximum Concentration (Tmax) of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
measure: Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
measure: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
measure: Apparent Volume of Distribution (Vz/F) of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
measure: Apparent Clearance (CL/F) of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
measure: Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
measure: Apparent Terminal Elimination Half-Life (t1/2) of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
measure: Amount of Pravastatin Excreted in Urine (Ae)
timeFrame: Day 1 (Period 1) and Day 7 (Period 2)
measure: Renal Clearance (CLR) of Pravastatin
timeFrame: Day 1 (Period 1) and Day 7 (Period 2)
measure: Percentage of Pravastatin Excreted in Urine (%Excreted)
timeFrame: Day 1 (Period 1) and Day 7 (Period 2)
measure: Plasma Concentrations of Pravastatin
timeFrame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of GDC-0810
timeFrame: Days 7-10 (Period 2)
measure: Time to Maximum Concentration (Tmax) of GDC-0810
timeFrame: Days 7-10 (Period 2)
measure: Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-0810
timeFrame: Days 7-10 (Period 2)
measure: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of GDC-0810
timeFrame: Days 7-10 (Period 2)
measure: Apparent Volume of Distribution (Vz/F) of GDC-0810
timeFrame: Days 7-10 (Period 2)
measure: Apparent Clearance (CL/F) of GDC-0810
timeFrame: Days 7-10 (Period 2)
measure: Apparent Terminal Elimination Rate Constant (lambda z) of GDC-0810
timeFrame: Days 7-10 (Period 2)
measure: Apparent Terminal Elimination Half-Life (t1/2) of GDC-0810
timeFrame: Days 7-10 (Period 2)
measure: Amount of GDC-0810 Excreted in Urine (Ae)
timeFrame: Day 7 (Period 2)
measure: Renal Clearance (CLr) of GDC-0810
timeFrame: Day 7 (Period 2)
measure: Percentage of GDC-0810 Excreted in Urine (%Excreted)
timeFrame: Day 7 (Period 2)
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: From baseline to study completion up to Day 28
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: From baseline to study completion up to Day 28
measure: Percentage of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Electrocardiograms (ECGs), Physical Examination Findings and Clinical Laboratory Results.
timeFrame: From baseline to study completion up to Day 28
measure: Plasma Concentrations of GDC-0810
timeFrame: Days 7-10 (Period 2)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
state: Florida
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: