A Study in Healthy Female Participants to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)

Phase 1 Completed 18 enrolled Janssen Sciences Ireland UC

NaSingle-groupOpen-labelOther

Summary

The main purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-56136379 on the single-dose pharmacokinetics (PK) of drospirenone and ethinylestradiol (oral contraceptive \[OC\]) in healthy female participants and to evaluate the effect of steady-state concentrations of JNJ-56136379 on the single-dose PK of midazolam (sensitive probe substrate for CYP3A4) in healthy female participants.

Timeline

Start: 2017-03-27
Primary completion: 2017-08-23
Completion: 2017-08-23

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	2 mg	Oral
Subject	drospirenone	Unknown	3 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.02 mg	Oral
Background	bersacapavir	Other / unclassified	170 mg	Oral

Indications

No indication recorded.