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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00915668

Collaborator

(none)

Enrollment

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics Drug Interactions Healthy	Drug: JNJ-31001074	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Anticipated Study Completion Date :

Mar 1, 2011

Outcome Measures

Primary Outcome Measures

Single-dose pharmacokinetics of a combination oral contraceptive when given in combination with JNJ-31001074. [Blood samples taken over a period of 48 hours after combination treatment]

Secondary Outcome Measures

To assess the multiple-dose pharmacokinetics of JNJ-31001074 in female volunteers [over a period of 9 days]
To assess the safety and tolerability of multiple doses of JNJ-31001074 while administered alone [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 [over a period of 3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.