Status:
WITHDRAWN
A Study to Evaluate the Pharmacokinetic Drug Interaction Between Multiple Doses of JNJ-31001074 and a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Women
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Pharmacokinetics
Drug Interactions
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
The main purpose of this research study is to evaluate the effect of multiple doses of an investigational drug known as JNJ-31001074 on the single dose of combination oral contraceptive Ovral-L contai...
Detailed Description
This is an open-label (both the physician and patient know which treatment will be administered), single center randomized, drug-drug interaction study in healthy female volunteers of non-child bearin...
Eligibility Criteria
Inclusion
- Women of non-child bearing potential (i.e., postmenopausal \[no spontaneous menses for at least 2 years\] or surgically sterile) 18 to 65 years of age, inclusive
- negative pregnancy test
- body mass index between 18 and 30
- body weight greater than or equal to 50 kilograms
Exclusion
- History of or current clinically significant medical illness
- abnormal lab values or physical exams
- pregnant or lactating
- used any hormonal products 3 months before study
- drug or alcohol abuse
- history of smoking or nicotine use, 2 weeks before start of study
- clinically significant allergy
- use of prescription and non-prescription medications within 2 weeks before the start of the study
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00915668
End Date
March 1 2011
Last Update
September 20 2016
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