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| ID | Type | Description | Link |
|---|---|---|---|
| 63623872FLZ1009 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-000639-34 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethinylestradiol/Norethindrone | Experimental | During the first oral contraceptive (OC) cycle participants will receive ethinylestradiol/norethindrone 35 microgram (mcg)/1 milligram (mg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in). During the second OC cycle (from Day 29 to Day 56), participants will receive ethinylestradiol/norethindrone 35 mcg/1 mg alone qd for 21 days on Days 29 to 49 (Cycle II: OC alone, reference). During the third OC cycle (from Day 57 to Day 84), participants will receive ethinylestradiol/norethindrone 35 mcg/1 mg qd for 21 days on Days 57 to 77 and in addition JNJ-63623872, 600 mg twice daily (bid) for 5 days on Days 73 to 77 (Cycle III: OC plus JNJ-63623872, test). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 77 of Cycle II |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| 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. |
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| 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. |
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| Area Under the Analyte Concentration versus Time Curve (AUC) From Time of Administration up to 12 Hours Post Dosing (AUC12h) of JNJ-63623872 | AUC12h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 12 hours post dosing. | 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. | 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). | 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. | 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. | 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. | 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 |
| 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. | 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 |
| Observed Analyte Concentration at 24 Hours Post Dosing (C24h) of Ethinylestradiol | C24h is the observed analyte concentration at 24 hours post dosing. | 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 |
| Observed Analyte Concentration at 24 Hours Post Dosing (C24h) of Norethindrone | C24h is the observed analyte concentration at 24 hours post dosing. | 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 |
| Minimum Observed Analyte Concentration (Cmin) of Ethinylestradiol | Cmin is the minimum observed analyte concentration. | 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 |
| Minimum Observed Analyte Concentration (Cmin) of Norethindrone | Cmin is the minimum observed analyte concentration. | 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 |
| Maximum Observed Analyte Concentration (Cmax) of Ethinylestradiol | Cmax is the maximum observed analyte concentration. | 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 |
| Maximum Observed Analyte Concentration (Cmax) of Norethindrone | Cmax is the maximum observed analyte concentration. | 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 |
| Time To Reach The Maximum Observed Analyte Concentration (Tmax) of Ethinylestradiol | Tmax is the actual sampling time to reach the maximum observed analyte concentration. | 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 |
| Time To Reach The Maximum Observed Analyte Concentration (Tmax) of Norethindrone | Tmax is the actual sampling time to reach the maximum observed analyte concentration. | 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 |
| Area Under the Analyte Concentration versus Time Curve (auc) From Time of Administration up to 24 Hours Post Dosing (AUC24h) of Ethinylestradiol | AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing. | 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 |
| Area Under the Analyte Concentration versus Time Curve (auc) From Time of Administration up to 24 Hours Post Dosing (AUC24h) of Norethindrone | AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing. | 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 |
| Average Steady-State Plasma Concentration (Cavg) of Ethinylestradiol | Cavg average steady-state plasma concentration. | 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 |
| Average Steady-State Plasma Concentration (Cavg) of Norethindrone | Cavg average steady-state plasma concentration. | 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 |
| Percentage Fluctuation (FI) of Ethinylestradiol | FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied ([Cmax - Cmin] / Cavg). | 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 |
| Percentage Fluctuation (FI) of Norethindrone | FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied ([Cmax - Cmin] / Cavg). | 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 of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/ref) of Ethinylestradiol | Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of ethinylestradiol. | 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 of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/ref) of Norethindrone | Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of Norethindrone. | 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 of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/ref) of Ethinylestradiol | Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Ethinylestradiol. | 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 of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/ref) of Norethindrone | Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Norethindrone. | 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 |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009640 | Norethindrone |
| C000605010 | pimodivir |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009652 | Norpregnenes |
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