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:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01240226
First received: November 10, 2010
Last updated: July 19, 2012
Last verified: July 2012

November 10, 2010
July 19, 2012
November 2010
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01240226 on ClinicalTrials.gov Archive Site
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Not Provided
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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
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: GDC-0941
    Oral repeating dose
  • Drug: ketoconazole
    Oral repeating dose
  • Experimental: A
    Interventions:
    • Drug: GDC-0941
    • Drug: ketoconazole
  • Experimental: B
    Interventions:
    • Drug: GDC-0941
    • Drug: ketoconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01240226
GDC4931g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Scott Holden, M.D. Genentech
Genentech
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP