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

NCT00915668 | Withdrawn Phase 1

• 1 other identifier: CR016261
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pharmacokinetics; Drug Interactions; Healthy

Keywords

Healthy women; Non-childbearing potential; Drug-drug interaction; Oral contraceptive; OC; Ovral-L; ethinyl estradiol; EE; levonorgestrel; JNJ-31001074

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Interventions

JNJ-31001074 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Interventions

bavisant

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 8, 2009
• Study Completion: March 1, 2011
• Last Updated: September 20, 2016

Record last verified: 2010-11