Status:
COMPLETED
A Study to Determine the Relative Bioavailability of a Tablet Formulation of GDC-0941 and the Effect of Ketoconazole on the Pharmacokinetics of the GDC-0941 Tablet
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This will be a single-center, open-label, randomized, 2-part study to determine the relative bioavailability of GDC-0941 capsule and market-image tablet formulations and the effect of ketoconazole on ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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)
- For female subjects: postmenopausal and without recent history of menorrhea, surgically sterile or using an effective method of contraception such as oral or transdermal contraceptives, double-barrier contraception, intrauterine device, depot progesterone, or implanted contraceptive devices, from Day -1 until 45 days after study drug completion/discharge; female subjects must have a negative pregnancy test at Screening and on Day -1
- For male subjects: sterile or a sterile sexual partner, or agreement to use 2 forms of medically acceptable methods of contraception, one of which is a barrier, and agreement not to donate sperm from Screening throughout the study period and for at least 3 months after the last dose of study drug.
- Exclusion Criteria
- History of clinical manifestations of significant metabolic (including type 1 and 2 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), urological, neurological, or psychiatric disease, or cancer
- History of inflammatory arthritis
- History of symptomatic hypotension
- History of severe physical injury, direct impact trauma, or neurological trauma within a specified timeframe prior to initiation of study treatment
- History of seizure disorders
- History of bipolar or major depressive disorder
- History of stomach or intestinal surgery or resection (except appendectomy, hernia repair, and cholecystectomy)
- History or presence of an abnormal ECG
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- History of alcoholism, drug abuse, or drug addiction
- Use of any nicotine-containing or nicotine-replacement products within a specified timeframe prior to initiation of study treatment
- Use of medications capable of inhibiting hepatic enzymes within a specified timeframe prior to initiation of study treatment
- Participation in any other investigational drug study in which receipt of an investigational study drug occurred within a specified timeframe prior to initiation of study treatment
- Use of any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within a specified timeframe prior to initiation of study treatment (2 weeks for antibiotics) (except hormone-replacement therapy or 2 weeks use of narcotics for pain)
- Any vaccination or immunization within a specified timeframe prior to initiation of study treatment
- Routine use of PPIs or histamine H2-receptor antagonists, or any use of these drugs within a specified timeframe prior to initiation of study treatment
- Known hypersensitivity to ketoconazole or other azole antifungals
- Use of any over-the-counter, nonprescription preparations (including supplements, vitamins, minerals, phytotherapeutic/herbal/plant-derived preparations, tryptophans, and St. John's wort) within a specified timeframe prior to initiation of study treatment
- Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within a specified timeframe prior to initiation of study treatment
- Donated blood within within a specified timeframe prior to initiation of study treatment
- Received blood products within a specified timeframe prior to initiation of study treatment
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01240226
Start Date
November 1 2010
End Date
December 1 2010
Last Update
March 3 2017
Active Locations (1)
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1
Investigational Site
Austin, Texas, United States, 78744