Skip to main content
OpenTrials
Completed

NCT Number: NCT01240226

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0941

Drug

Oral repeating dose

Ketoconazole

Drug

Oral repeating dose

Primary outcomes

  1. Incidence, nature, and severity of adverse events

    Time frame: Through study completion or early study discontinuation

  2. Pharmacokinetic parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)

    Time frame: Prior to and after GDC-0941 dosing

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 15, 2010
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.