CompletedNCT02621957Updated Nov 2, 2016

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

A Phase 1 interventional study of GDC-0810 and Pravastatin in Breast Cancer, sponsored by Genentech, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: Female

Study 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.

Conditions studied

Breast Cancer

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

Experimental
Female Healthy Volunteers
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.
Drug: GDC-0810 · Drug: Pravastatin

Interventions

DrugGDC-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).
Also known as: ARN-810
DrugPravastatin
Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.
Also known as: Pravachol

What researchers measure

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)

Study locations

1 site

Daytona Beach, Florida 32117, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02621957
Lead sponsor: Genentech, Inc.
Responsible party: Sponsor
First posted: Dec 4, 2015
Start date: Dec 2015
Primary completion: Feb 2016
Completion: Feb 2016
Last update: Nov 2, 2016

Study contacts

Clinical Trials

study director · Hoffmann-La Roche

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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