Status:
COMPLETED
A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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,...
Detailed Description
This is an open-label (both the physician and healthy volunteer know which treatment will be administered), sequential design (one after the other) study to assess the pharmacokinetics (process by whi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00915746
Start Date
November 1 2009
End Date
December 1 2009
Last Update
April 30 2010
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