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| ID | Type | Description | Link |
|---|---|---|---|
| 64155806FLZ1001 | Other Identifier | Janssen Research & Development, LLC |
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Study stopping rules were met.
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The primary purpose of this study is to evaluate the effect of single and multiple doses of JNJ-64155806 on the steady-state pharmacokinetics (PK) of ethinylestradiol and drospirenone and vice versa in healthy female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-64155806+COCP+JNJ-64155806 with COCP | Experimental | Participants will receive JNJ-64155806 150 milligram (mg) twice daily (BID) under fed conditions on Days 1 to 7 [JNJ-64155806 Alone Phase] followed by a 10-day washout phase; followed by Ethinylestradiol/drospirenone 0.02 mg/3 mg given as a combined oral contraceptive pill (COCP) once daily (QD) on Days 18 to 41 and COCP placebo QD on Days 42 to 45 [COCP Lead-in Phase]; further followed by COCP QD on Days 46 to 69 (on Days 59 to 66 under fed condition), JNJ-64155806 150 mg BID (under fed conditions) on Days 60 to 66, and COCP placebo QD on Days 70 to 73 [JNJ-64155806 + COCP Co-administration Phase]. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64155806 150 mg | Drug | JNJ-64155806 150 mg (3*50 mg tablet) twice daily will be administered under fed conditions on Days 1 to 7 [JNJ-64155806 Alone Phase] and on Days 60 to 66 [JNJ-64155806 + COCP Coadministration Phase]. |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Plasma Concentration (Ctrough) for Ethinylestradiol | The Ctrough is the plasma concentration before dosing. | Days 57, 58, 59, 60, 66 |
| Trough Plasma Concentration (Ctrough) for Drospirenone | The Ctrough is the plasma concentration before dosing. | Days 57, 58, 59, 60, 66 |
| Minimum Observed Plasma Concentration (Cmin) for Ethinylestradiol | The Cmin is the minimum observed plasma concentration. | Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose |
| Minimum Observed Plasma Concentration (Cmin) for Drospirenone | The Cmin is the minimum observed plasma concentration. | Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) for Ethinylestradiol | The Cmax is the maximum observed plasma concentration. | Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) for Drospirenone | The Cmax is the maximum observed plasma concentration. | Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for Ethinylestradiol | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Signing of Informed Consent Form (ICF) till End of Study (Day 73) |
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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 |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| C035144 | drospirenone |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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| Ethinylestradiol/drospirenone 0.02 mg/3 mg | Drug | Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol administered as combined oral contraceptive pill (COCP) given on Days 18 to 41 (lead-in phase), Days 46 to 69 (coadministration phase - Days 59 to 66 under fed conditions). |
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| COCP Placebo | Drug | Participant will receive COCP placebo tablets once daily on Days 42 to 45 (lead-in phase) and Days 70 to 73 (JNJ-64155806 + COCP coadministration phase). |
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| Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for Drospirenone | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Days 59, 60, 66: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours postdose |
| Average Plasma Concentration (C24h) at 24hours for Ethinylestradiol | C24h is observed analyte concentration at 24 hours. | Days 59, 60, 66 |
| Average Plasma Concentration (C24h) at 24hours for Drospirenone | C24h is observed analyte concentration at 24 hours. | Days 59, 60, 66 |
| Average Plasma Concentration (Cavg) for Ethinylestradiol | Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval]. | Days 59, 60, 66 |
| Average Plasma Concentration (Cavg) for Drospirenone | Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval]. | Days 59, 60, 66 |
| Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Ethinylestradiol | The AUC(0-24h) is the area under the plasma concentration time curve from time zero to 24 hours. | Days 59, 60, 66 |
| Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24h]) for Drospirenone | The AUC(0-24h) is the area under the plasma concentration time curve from time zero to 24 hours. | Days 59, 60, 66 |
| Fluctuation Index (FI) for Ethinylestradiol | FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg). | Days 59, 60, 66 |
| Fluctuation Index (FI) for Drospirenone | FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg). | Days 59, 60, 66 |
| Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Ethinylestradiol | Ratio Cmin,test/ref is the ratio of individual Cmin values between test and reference treatment. Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone). | Days 59, 60, 66 |
| Ratio of Cmin Values Between Test and Reference (Ratio Cmin,test/ref) for Drospirenone | Ratio Cmin,test/ref is the ratio of individual Cmin values between test and reference treatment. Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone). | Days 59, 60, 66 |
| Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Ethinylestradiol | Ratio Cmax,test/ref is the ratio of individual Cmax values between test and reference treatment. Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone). | Days 59, 60, 66 |
| Ratio of Cmax Values Between Test and Reference Treatment (Ratio Cmax,test/ref) for Drospirenone | Ratio Cmax,test/ref is the ratio of individual Cmax values between test and reference treatment. Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone). | Days 59, 60, 66 |
| Ratio of AUC(0-24h) Values Between Test and Reference (Ratio AUC[0-24h],test/ref) for Ethinylestradiol | Ratio AUC(0-24h),test/ref is the ratio of individual AUC(0-24h) values between test and reference treatment. Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone). | Days 59, 60, 66 |
| Ratio of AUC(0-24h) Values Between Test and Reference Treatment (Ratio AUC[0-24h],test/ref) for Drospirenone | Ratio AUC(0-24h),test/ref is the ratio of individual AUC(0-24h) values between test and reference treatment. Test is Day 60 (JNJ-64155806 single dose + ethinylestradiol/drospirenone) or Day 66 (JNJ-64155806 multiple dose + ethinylestradiol/drospirenone) and Reference is Day 59 (ethinylestradiol/drospirenone alone). | Days 59, 60, 66 |
| Minimum Observed Plasma Concentration (Cmin) for JNJ-64155806 | The Cmin is the minimum observed plasma concentration. | Days 1, 7, 60, 66 |
| Maximum Observed Plasma (Cmax) for JNJ-64155806 | The Cmax is the maximum observed plasma concentration. | Days 1, 7, 60, 66 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for JNJ-64155806 | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Days 1, 7, 60, 66 |
| Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12h]) for JNJ-64155806 | The AUC(0-12h) is the area under the plasma concentration time curve from time zero to 12 hours. | Days 1, 7, 60, 66 |
| Area Under the Plasma Concentration-time Curve From 12 Hours to 24 Hours (AUC[12-24h]) for JNJ-64155806 | The AUC(12h-24h) is the area under the plasma concentration time curve from time 12 hours to 24 hours. | Days 1, 7, 60, 66 |
| Trough Plasma Concentration (Ctrough) for JNJ-64155806 | Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen. | Days 5, 6, 7, 64, 65, 66 |
| Average Analyte Concentration (Cavg) for JNJ-64155806 | Cavg is average analyte concentration at steady state, calculated as: AUC24h/24 hours at steady state [24 hours equal to (=) dosing interval]. | Days 7 and 66 |
| Fluctuation Index (FI) for JNJ-64155806 | FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state). | Days 7 and 66 |
| 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 |