Clinical trial NCT03249402: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) in Cycle 1
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) in Cycle 2
timeFrame: 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
measure: Trough Plasma Concentration (Ctrough) in Cycle 1
timeFrame: Cycle1: Predose (Day 21)
measure: Trough Plasma Concentration (Ctrough) in Cycle 2
timeFrame: Cycle 2: Predose (Day 21)
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 1
timeFrame: 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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 2
timeFrame: 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:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 87 Days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Life Science Services
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: