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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
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.
Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.
SGS Life Science Services
Antwerp, Belgium
Maximum Observed Plasma Concentration (Cmax) in Cycle 1
The Cmax is the maximum observed plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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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.
Time frame: Up to 87 Days