NCT03126097

A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females

A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Drug-drug Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the effect of single and multiple doses of JNJ-64155806 on the steady-state pharmacokinetics (PK) of ethinylestradiol and drospirenone and vice versa in healthy female participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-64155806 150 mg	JNJ-64155806 150 mg (3\*50 mg tablet) twice daily will be administered under fed conditions on Days 1 to 7 \[JNJ-64155806 Alone Phase\] and on Days 60 to 66 \[JNJ-64155806 + COCP Coadministration Phase\].
DRUG	Ethinylestradiol/drospirenone 0.02 mg/3 mg	Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol administered as combined oral contraceptive pill (COCP) given on Days 18 to 41 (lead-in phase), Days 46 to 69 (coadministration phase - Days 59 to 66 under fed conditions).
DRUG	COCP Placebo	Participant will receive COCP placebo tablets once daily on Days 42 to 45 (lead-in phase) and Days 70 to 73 (JNJ-64155806 + COCP coadministration phase).

Timeline

• Start date: 2017-04-13
• Primary completion: 2017-05-26
• Completion: 2017-05-26
• First posted: 2017-04-24
• Last updated: 2017-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study