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

• Status: Withdrawn
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Levonorgestrel; Polyestradiol phosphate

Criteria

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