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

Healthy Clinical Trial

Official title:

An Open-label Drug-drug Interaction Study in Healthy Female Adult Subjects to Investigate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249402
• Other study ID #: CR108351
• Secondary ID: 2016-004725-1642
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2017
• Last updated: December 8, 2017
• Start date: August 14, 2017
• Est. completion date: November 24, 2017

Study information

• Verified date: December 2017
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 24, 2017
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Ethinyl Estradiol + Levonorgestrel
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.
• JNJ-42847922
Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.

Locations

Country	Name	City	State
Belgium	SGS Life Science Services	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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
Primary	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	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 87 Days