Healthy Volunteer
Conditions
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 the pharmacokinetics of the GDC-0941 market-image tablet formulation.
Interventions
DRUGGDC-0941
Oral repeating dose
DRUGketoconazole
Oral repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of adverse events | Through study completion or early study discontinuation |
| Pharmacokinetic parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration) | Prior to and after GDC-0941 dosing |
Countries
United States
Outcome results
None listed