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

This study has been withdrawn prior to enrollment.
(The trial is postponed pending the completion of other ongoing pre-clinical and clinical work.)
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00915668
First received: June 4, 2009
Last updated: November 24, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Pharmacokinetics
Drug Interactions
Healthy
Drug: JNJ-31001074
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the multiple-dose pharmacokinetics of JNJ-31001074 in female volunteers [ Time Frame: over a period of 9 days ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of multiple doses of JNJ-31001074 while administered alone [ Time Frame: over a period of 6 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Estimated Study Completion Date: March 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915668

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.
  More Information

No publications provided

Responsible Party: Clinical Leader Psychiatry, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00915668     History of Changes
Other Study ID Numbers: CR016261
Study First Received: June 4, 2009
Last Updated: November 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Healthy women
Non-childbearing potential
Drug-drug interaction
Oral contraceptive
OC
Ovral-L
ethinyl estradiol
EE
levonorgestrel
JNJ-31001074

Additional relevant MeSH terms:
Estradiol
Ethinyl Estradiol
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 16, 2014