A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers (NCT00915746) | Clinical Trial Compass
CompletedPhase 1
A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
14 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: Multiple blood samples will be obtained over the 11 day open-label treatment phase
Trial details
NCT IDNCT00915746
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.