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.
Looking for future studies?
Notify MeKey information
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)
Interested in participating?
Looking for future studies?
Notify MeSponsors 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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
HIIT Following Breast Cancer Chemotherapy
NCT05913713
Breast Cancer, Breast Diseases
Gainesville, Florida, United States
View Trial DetailsCDK and Body Composition Study
NCT03697577
Breast Cancer, Breast Diseases
The Bronx, New York, United States
View Trial DetailsNeoadjuvant Inetetamab and Pyrotinib and Nab-paclitaxel for HER2+Breast Cancer
NCT05444998
Breast Cancer, Breast Diseases
Xi'an, Shannxi, China
View Trial DetailsHER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer
NCT03387553
Breast Cancer, Breast Cancer Female
Tampa, Florida, United States
View Trial Details