NCT01473316
Completed
Phase 1
An Open-Label, Fixed-Sequence, 2-Period Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
Overview
- Phase
- Phase 1
- Intervention
- GDC-0980
- Conditions
- Healthy Volunteer
- Sponsor
- Genentech, Inc.
- Enrollment
- 22
- Primary Endpoint
- Pharmacokinetics: maximum observed plasma concentration
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This will be an open-label, fixed-sequence, single-center, 2 period study. The study is designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy postmenopausal and/or surgically sterile adult nonsmoking female subject between 18 and 65 years of age, inclusive, with a body mass index of 18 to 32 kg/m2, inclusive
- •Medically healthy as determined by the absence of clinically significant findings in the physical examination, medical history, vital sign measurements, clinical laboratory tests, or 12 lead electrocardiograms (ECGs) as determined by the investigator
- •Female subject of nonchildbearing potential
Exclusion Criteria
- •History or clinical manifestations of significant metabolic (including type 1 and 2 diabetes), hepatic, renal, hematological (including hypercholesterolemia and triglyceridemia), pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), urological, neurological, or psychiatric disorders, or cancer
- •History of inflammatory arthritis
- •History of symptomatic hypotension
- •History of severe physical injury, direct impact trauma, or neurological trauma within 6 months before Day 1 of Period 1
- •History of seizure disorders
- •History of bipolar or major depressive disorder
- •History of stomach or intestinal surgery or resection that could potentially alter absorption and/or excretion of orally administered drugs, with the exception of appendectomy, hernia repair, and cholecystectomy, which are allowed
- •History of active liver disease, including hepatitis or cirrhosis
- •History or presence of an abnormal ECG
- •History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
Arms & Interventions
A
Intervention: GDC-0980
A
Intervention: Ketoconazole
Outcomes
Primary Outcomes
Pharmacokinetics: maximum observed plasma concentration
Time Frame: Up to approximately 10 days
Pharmacokinetics: time to reach maximum observed plasma concentration
Time Frame: Up to approximately 10 days
Secondary Outcomes
- Adverse events(Up to approximately 40 days)
- Vital sign measurements (sitting systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature)(Up to approximately 8 days)
- Clinical laboratory test results (hematology and serum chemistry)(Up to approximately 10 days)
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