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Completed

NCT Number: NCT02652650

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethinylestradiol

Drug

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.

Norethindrone

Drug

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-63623872

Drug

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.

Primary outcomes

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

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

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

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

    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

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

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

    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

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

  4. Minimum Observed Analyte Concentration (Cmin) of JNJ-63623872

    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

    Cmin is the minimum observed analyte concentration.

  5. Maximum Observed Analyte Concentration (Cmax) of JNJ-63623872

    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

    Cmax is the maximum observed analyte concentration.

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

    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

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

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

    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

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

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

    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

    Cavg is the average steady-state plasma concentration.

  9. Percentage Fluctuation (FI) of JNJ-63623872

    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

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

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

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

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

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

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

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

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

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

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

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

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

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

  14. Observed Analyte Concentration at 24 Hours Post Dosing (C24h) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    C24h is the observed analyte concentration at 24 hours post dosing.

  15. Observed Analyte Concentration at 24 Hours Post Dosing (C24h) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    C24h is the observed analyte concentration at 24 hours post dosing.

  16. Minimum Observed Analyte Concentration (Cmin) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Cmin is the minimum observed analyte concentration.

  17. Minimum Observed Analyte Concentration (Cmin) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Cmin is the minimum observed analyte concentration.

  18. Maximum Observed Analyte Concentration (Cmax) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Cmax is the maximum observed analyte concentration.

  19. Maximum Observed Analyte Concentration (Cmax) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Cmax is the maximum observed analyte concentration.

  20. Time To Reach The Maximum Observed Analyte Concentration (Tmax) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

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

  21. Time To Reach The Maximum Observed Analyte Concentration (Tmax) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

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

  22. Area Under the Analyte Concentration versus Time Curve (auc) From Time of Administration up to 24 Hours Post Dosing (AUC24h) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.

  23. Area Under the Analyte Concentration versus Time Curve (auc) From Time of Administration up to 24 Hours Post Dosing (AUC24h) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.

  24. Average Steady-State Plasma Concentration (Cavg) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Cavg average steady-state plasma concentration.

  25. Average Steady-State Plasma Concentration (Cavg) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Cavg average steady-state plasma concentration.

  26. Percentage Fluctuation (FI) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

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

  27. Percentage Fluctuation (FI) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

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

  28. Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/ref) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of ethinylestradiol.

  29. Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/ref) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of Norethindrone.

  30. Ratio of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/ref) of Ethinylestradiol

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Ethinylestradiol.

  31. Ratio of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/ref) of Norethindrone

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 49 of Cycle II; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle III

    Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Norethindrone.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2016
Registry last updated
Jun 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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