NCT03249402

A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants

An Open-label Drug-drug Interaction Study in Healthy Female Adult Subjects to Investigate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ethinyl Estradiol + Levonorgestrel	Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.
DRUG	JNJ-42847922	Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.

Timeline

• Start date: 2017-08-14
• Primary completion: 2017-11-24
• Completion: 2017-11-24
• First posted: 2017-08-15
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium