Daytona Beach, Florida, 32117, United States
NCT Number: NCT02621957
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.
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Conditions
Age range
18 year–65 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
GDC-0810
DrugDuring 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).
Other names: ARN-810
Pravastatin
DrugSubjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.
Other names: Pravachol
Primary outcomes
-
Maximum Observed Concentration (Cmax) of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
-
Time to Maximum Concentration (Tmax) of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
-
Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
-
Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
-
Apparent Volume of Distribution (Vz/F) of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
-
Apparent Clearance (CL/F) of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
-
Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
-
Apparent Terminal Elimination Half-Life (t1/2) of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
-
Amount of Pravastatin Excreted in Urine (Ae)
Time frame: Day 1 (Period 1) and Day 7 (Period 2)
-
Renal Clearance (CLR) of Pravastatin
Time frame: Day 1 (Period 1) and Day 7 (Period 2)
-
Percentage of Pravastatin Excreted in Urine (%Excreted)
Time frame: Day 1 (Period 1) and Day 7 (Period 2)
-
Plasma Concentrations of Pravastatin
Time frame: Days 1-3 (Period 1) and Days 7-10 (Period 2)
Secondary outcomes
-
Maximum Observed Concentration (Cmax) of GDC-0810
Time frame: Days 7-10 (Period 2)
-
Time to Maximum Concentration (Tmax) of GDC-0810
Time frame: Days 7-10 (Period 2)
-
Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-0810
Time frame: Days 7-10 (Period 2)
-
Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of GDC-0810
Time frame: Days 7-10 (Period 2)
-
Apparent Volume of Distribution (Vz/F) of GDC-0810
Time frame: Days 7-10 (Period 2)
-
Apparent Clearance (CL/F) of GDC-0810
Time frame: Days 7-10 (Period 2)
-
Apparent Terminal Elimination Rate Constant (lambda z) of GDC-0810
Time frame: Days 7-10 (Period 2)
-
Apparent Terminal Elimination Half-Life (t1/2) of GDC-0810
Time frame: Days 7-10 (Period 2)
-
Amount of GDC-0810 Excreted in Urine (Ae)
Time frame: Day 7 (Period 2)
-
Renal Clearance (CLr) of GDC-0810
Time frame: Day 7 (Period 2)
-
Percentage of GDC-0810 Excreted in Urine (%Excreted)
Time frame: Day 7 (Period 2)
-
Percentage of Participants with Adverse Events (AEs)
Time frame: From baseline to study completion up to Day 28
-
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: From baseline to study completion up to Day 28
-
Percentage of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Electrocardiograms (ECGs), Physical Examination Findings and Clinical Laboratory Results.
Time frame: From baseline to study completion up to Day 28
-
Plasma Concentrations of GDC-0810
Time frame: Days 7-10 (Period 2)
Sponsors and collaborators
Lead sponsor
Genentech, Inc.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Dec 4, 2015
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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