A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants

NCT03249402 | Completed Phase 1

• 3 other identifiers: CR1083512016-004725-1642847922MDD1003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) in Cycle 1

  The Cmax is the maximum observed plasma concentration.

  Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose

• Maximum Observed Plasma Concentration (Cmax) in Cycle 2

  The Cmax is the maximum observed plasma concentration.

  Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose

• Trough Plasma Concentration (Ctrough) in Cycle 1

  The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.

  Cycle1: Predose (Day 21)

• Trough Plasma Concentration (Ctrough) in Cycle 2

  The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.

  Cycle 2: Predose (Day 21)

• Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 1

  The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.

  Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose

• Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 2

  The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.

  Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose

Secondary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to 87 Days

Study Arms (1)

Oral Contraceptive Tablet + JNJ-42847922

EXPERIMENTAL

All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period).

Drug: Ethinyl Estradiol + Levonorgestrel; Drug: JNJ-42847922

Interventions

Ethinyl Estradiol + Levonorgestrel DRUG

Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.

Also known as: Microgynon 30

Oral Contraceptive Tablet + JNJ-42847922

JNJ-42847922 DRUG

Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.

Oral Contraceptive Tablet + JNJ-42847922

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be female of childbearing potential (women with tubal ligation are not accepted)
• Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23 within the range of 18 to 30 kilogram / square meter (kg/m\^2) inclusive
• Have a systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, and diastolic blood pressure no higher than 90 mmHg
• Agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last dose of study drug
• Have a negative serum pregnancy test at screening and a negative predose urine pregnancy test on Day1 and Day 21 of Cycle 1 and Cycle 2

You may not qualify if:

• Participant has a past history of heart arrhythmias (extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
• Participant is currently pregnant or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving the last dose of study drug)
• Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for HBsAg or hepatitis C virus antibody at screening.
• Participant has a history of or present allergy to the oral contraceptive (OC) or JNJ-42847922, or drugs of these classes, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
• Participant has a history of alcohol/drug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging greater than (\>) 14 drinks/week for women within 6 months of screening

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (1)

SGS Life Science Services

Antwerp, 2060, Belgium

Location

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination; seltorexant

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: August 14, 2017
• Primary Completion: November 24, 2017
• Study Completion: November 24, 2017
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

BE (1)