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

NCT ID: NCT01240226

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

GDC-0941

Intervention Type: DRUG

Oral repeating dose

ketoconazole

Intervention Type: DRUG

Oral repeating dose

B

Group Type: EXPERIMENTAL

GDC-0941

Intervention Type: DRUG

Oral repeating dose

ketoconazole

Intervention Type: DRUG

Oral repeating dose

Interventions

GDC-0941

Oral repeating dose

Intervention Type: DRUG

GDC-0941

Oral repeating dose

Intervention Type: DRUG

ketoconazole

Oral repeating dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Holden, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Investigational Site

Austin, Texas, United States

Countries

United States

Other Identifiers

GDC4931g

Identifier Type: -

Identifier Source: org_study_id