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
This study has been completed.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01240226
First received: November 10, 2010
Last updated: July 19, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: GDC-0941 Drug: ketoconazole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, 2-Part 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration) [ Time Frame: Prior to and after GDC-0941 dosing ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: GDC-0941
Oral repeating dose
Drug: ketoconazole
Oral repeating dose
|
| Experimental: B |
Drug: GDC-0941
Oral repeating dose
Drug: ketoconazole
Oral repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01240226 History of Changes |
| Other Study ID Numbers: | GDC4931g |
| Study First Received: | November 10, 2010 |
| Last Updated: | July 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ketoconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013