A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers

NCT00915746 | Completed Phase 1

• 1 other identifier: CR016342
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label (both the physician and healthy volunteer know which treatment will be administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of study/early withdrawal assessment phase.

Conditions

Healthy; Pharmacokinetics; Drug Interactions

Keywords

Phase I; ketoconazole; CYP3A4 inhibitor; drug interaction; metabolism; Healthly Volunteer; JNJ-31001074

Outcome Measures

Primary Outcomes (1)

• The primary objective is to assess the effects of repeated daily administration of 400 mg of ketoconazole on the single-dose pharmacokinetics of JNJ-31001074 in healthy volunteers

  Multiple blood samples will be obtained over the 11 day open-label treatment phase

Secondary Outcomes (1)

• To assess the safety and tolerability of JNJ-31001074 with and without coadministration of ketoconazole

  up to 32 days (including a 21 day screening phase)

Interventions

JNJ-31001074; ketoconazole DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteer between the ages of 18-55
• if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test
• body mass index between 18-30
• body weight greater than or equal to 50 kilograms
• blood pressure between 90 and 140 mgHg systolic and no higher than 90 mgHg diastolic
• nonsmoker

You may not qualify if:

• History of or current clinically significant medical illness
• clinically significant abnormal laboratory value(s)
• clinically significant abnormal physical examination, vital signs or electrocardiogram
• pregnant, lactating or completed last term pregnancy within six months of screening
• use of any prescription or non prescription medication except for paracetamol (acetaminophen/TYLENOL), bisphosphonates (drugs to treat osteoporosis), hormone replacement therapy within 14 days of first dose of study medication
• history of drug or alcohol abuse
• history of smoking or use of nicotine-containing substances within the previous two months

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Interventions

bavisant; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 8, 2009
• Study Start: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 30, 2010

Record last verified: 2010-04