- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00915668
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
September 19, 2016 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label, Randomized, Crossover Drug-Drug Interaction Study to Assess the Effects of Multiple Doses of JNJ-31001074 on the Pharmacokinetics of a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel
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 containing ethinyl estradiol and levonorgestrel in healthy women who cannot bear children.
This study will look at the safety, tolerability (how the drug makes you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in combination in healthy women.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 bearing potential.
A total of 32 volunteers will be enrolled.
The study consists of a screening phase, an open label treatment period, and end of study/early withdrawal assessments.
Volunteers will be randomly assigned to 1 of 2 treatment sequences.
The open-label treatment phase will consist of two periods.
In each period, volunteers will receive either of the following treatment(s): Treatment A: a single dose of oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel (Ovral-L) on Day 1 and Treatment B: multiple daily doses of 10 mg JNJ-31001074 on Days 1 to 8 and a single dose of oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel (Ovral-L) on Day 7. A washout (no treatment break or drug holiday) period of 28 days separates the two occasions of single dose administration of oral contraceptives in Periods 1 and 2. Safety and tolerability will be assessed from the time of informed consent to the end-of-study evaluations or early withdrawal.
Volunteers will be instructed to report any serious adverse events that occur up to 30 days following the last dose of study drugs.
For Treatment A, the volunteer will receive a single dose of oral contraceptive.
For Treatment B, the volunteer will receive 10 mg tablet of JNJ-31001074 once daily orally for eight days (Days 1 to 8) and a single dose of oral contraceptive on Day 7.
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Single-dose pharmacokinetics of a combination oral contraceptive when given in combination with JNJ-31001074.
Time Frame: Blood samples taken over a period of 48 hours after combination treatment
|
Blood samples taken over a period of 48 hours after combination treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the multiple-dose pharmacokinetics of JNJ-31001074 in female volunteers
Time Frame: over a period of 9 days
|
over a period of 9 days
|
To assess the safety and tolerability of multiple doses of JNJ-31001074 while administered alone
Time Frame: over a period of 6 days
|
over a period of 6 days
|
To assess the safety and tolerability of multiple doses of JNJ-31001074 while administered together with a single-dose of an oral contraceptive in healthy female volunteers
Time Frame: over a period of 3 days
|
over a period of 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Anticipated)
March 1, 2011
Study Registration Dates
First Submitted
June 4, 2009
First Submitted That Met QC Criteria
June 4, 2009
First Posted (Estimate)
June 8, 2009
Study Record Updates
Last Update Posted (Estimate)
September 20, 2016
Last Update Submitted That Met QC Criteria
September 19, 2016
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR016261
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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