A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Healthy
Interventions
DRUG

Ethinylestradiol

Participants will receive 35 microgram (mcg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle.

DRUG

Norethindrone

Participants will receive 1 milligram (mg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle.

DRUG

JNJ-63623872

Participants will receive 600 mg twice daily (bid) for 5 days on Days 73 to 77 (Cycle III: OC plus JNJ-63623872, test) during third OC cycle under fed conditions.

Trial Locations (1)

Unknown

Merksem

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02652650 - A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone | Biotech Hunter | Biotech Hunter