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

Janssen Research & Development, LLC18 enrolled

Overview

The purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone in healthy female participants.

This is a Phase 1 and open-label study. The study consists of Screening Phase (less than or equal to (\<=) 28 days before Day 1), Treatment Phase (Day 1 up to Day 78) and Follow up Phase (10 to 14 days after last study drug intake or, if an adverse event occurs, 30 to 35 days after last study drug intake). Treatment phase will consist of three Oral Contraceptive (OC) cycles (each cycle consists of 21 days of ethinylestradiol/norethindrone followed by 7 pill-free days). The duration of the treatment phase, including the OC-free period of Cycles I and II, will be 78 days. Blood samples will be collected for measurement of pharmacokinetic (Pk) parameters. Participants' safety will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

EthinylestradiolDRUG

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.

NorethindroneDRUG

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.

JNJ-63623872DRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol * Participants must, if heterosexually active with a partner who is not vasectomized (confirmed sterile), be practicing an effective method of contraception before entry and agree to continue to use two effective methods of contraception throughout the study and for at least 30 days after receiving the last intake of oral contraceptive (OC) plus JNJ-63623872 on Day 77 * Participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 of Cycle I * Participants must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last intake of OC plus JNJ-63623872 on Day 77 * Participants must have a Body Mass Index (BMI); between 18.0 and 30.0 kilogram per square meter (kg/m\^2) (extremes included) Exclusion Criteria: * Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results * At screening, participants with one or more of the laboratory abnormalities specified in the protocol as defined by the World Health Organization (WHO) Toxicity Grading Scale * Participant with a past history of heart arrhythmias (extrasystole, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome) * Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticarial * Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs

Locations (1)

Unnamed facility

Merksem, Belgium

Outcomes

Primary Outcomes

Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872

Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.

Time frame: Post-dose on Days 75 and 76 of Cycle III

Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of JNJ-63623872

Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II

Observed Analyte Concentration at 12 Hours Post Dosing (C12h) of JNJ-63623872

C12h is the observed analyte concentration at 12 hours post dosing.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II

Minimum Observed Analyte Concentration (Cmin) of JNJ-63623872

Cmin is the minimum observed analyte concentration.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II

Maximum Observed Analyte Concentration (Cmax) of JNJ-63623872

Cmax is the maximum observed analyte concentration.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II

Time To Reach The Maximum Observed Analyte Concentration (Tmax) of JNJ-63623872

Tmax is the actual sampling time to reach the maximum observed analyte concentration.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II

Area Under the Analyte Concentration versus Time Curve (AUC) From Time of Administration up to 12 Hours Post Dosing (AUC12h) of JNJ-63623872

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

AUC12h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 12 hours post dosing.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II

Average Steady-State Plasma Concentration (Cavg) of JNJ-63623872

Cavg is the average steady-state plasma concentration.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II

Percentage Fluctuation (FI) of JNJ-63623872

FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied (\[Cmax - Cmin\] / Cavg).

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II

Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Ethinylestradiol

Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.

Time frame: Post-dose on Days 47 and 48 of Cycle II; post-dose on Days 75 and 76 of Cycle III

Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Norethindrone

Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.

Time frame: Post-dose on Days 47 and 48 of Cycle II; post-dose on Days 75 and 76 of Cycle III

Observed Analyte Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) of Ethinylestradiol

Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.