NCT03111511View on ClinicalTrials.gov

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)

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

March 27, 2017

Primary Completion Date

August 23, 2017

Study Completion Date

August 23, 2017

Conditions

Healthy

Interventions

DRUG

Drospirenone/Ethinylestradiol

A single dose of drospirenone/ethinylestradiol 3 mg/0.02 mg (OC) tablets on Days 1 and 21.

DRUG

Midazolam

Midazolam 2 mg orally on Days 1 and 21.

DRUG

JNJ-56136379

JNJ-56136379 dose will be administered orally at a dose of 250 mg (as 2 tablets of 100 mg + 2 tablets of 25 mg) on Days 6 and 7 and at a dose of 170 mg (as 1 tablet of 100 mg+ 2 tablets of 25 mg + 4 tablets of 5 mg) on Days 8 to 25.

Trial Locations (1)

2170

Clinical Pharmacology Unit, Merksem

All Listed Sponsors

lead

Janssen Sciences Ireland UC

INDUSTRY

NCT03111511 - 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) | Biotech Hunter | Biotech Hunter