NCT03890341

Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440

A Study in Healthy Female Participants to Investigate the Effect of JNJ-64530440 on the Single-dose of Ethinylestradiol and Drospirenone (Oral Contraceptive), and Midazolam, and the Effect of a High-fat Meal on the Single-dose of JNJ-64530440

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of JNJ-64530440 single- and multiple-dose administration on the single-dose pharmacokinetics of drospirenone and ethinylestradiol (oral contraceptive) in healthy female participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Drospirenone/Ethinylestradiol	A single oral dose of drospirenone/ethinylestradiol 3 mg/0.02 mg (OC) tablets will be administered on Days 1, 13 and 19.
DRUG	Midazolam	Midazolam 2 mg will be administered orally on Days 1, 13 and 19.
DRUG	JNJ-64530440	A single oral dose of JNJ-64530440 2,000 mg will be administered on Day 6 and once daily on Days 13 to 22.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-08-01
• Completion: 2021-11-01
• First posted: 2019-03-26
• Last updated: 2021-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study