Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Ketoconazole

Drug: GDC-0980

Study type

Interventional

Funder types

Industry

Identifiers

NCT01473316

GP27913

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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
Abnormality on the chest x-ray at Screening determined to be clinically significant by the investigator and medical monitor
History of alcoholism, drug abuse, or drug addiction
Used any nicotine-containing or nicotine-replacement products within 6 months before Day 1 of Period 1
Participated in any other investigational drug study in which receipt of an investigational study drug occurred within 1 month or 5 half-lives before Day 1 of Period 1
Used any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within 1 month (2 weeks for antibiotics) before Day 1 of Period 1, with the exception of hormone replacement therapy or 2 weeks' use of narcotics for pain, unless deemed acceptable by the investigator
Used medications capable of inhibiting hepatic enzymes within 1 month or 5 half-lives before Day 1 of Period 1
Received any vaccination or immunization within 1 month before Day 1 of Period 1
Used proton pump inhibitors or histamine H2 receptor antagonists within 1 month before Day 1 of Period 1
Known hypersensitivity to ketoconazole, or other azole antifungals
Used any over-the-counter, nonprescription preparations within 7 days before Day 1 of Period 1, unless deemed acceptable by the investigator
Used alcohol-containing, grapefruit-containing, or caffeine containing foods or beverages within 72 hours before Day 1 of Period 1, unless deemed acceptable by the investigator
Poor peripheral venous access
Donated blood within 2 weeks or plasma within 1 week before Day 1 of Period 1
Received blood products within 2 months before Day 1 of Period 1
Positive urine drug or alcohol screen
Positive screen for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus types 1 and 2
Diagnosed with a vitamin B12 deficiency
Any acute or chronic condition that, in the opinion of the investigator, would limit the subject's ability to complete or participate in this clinical study