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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Ketoconazole

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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