Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ethinylestradiol · 2 trials · 1 indication
The Cmax is the maximum observed plasma concentration.
The Cmax is the maximum observed plasma concentration.
The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.
The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
C12h is the observed analyte concentration at 12 hours post dosing.
Cmin is the minimum observed analyte concentration.
Cmax is the maximum observed analyte concentration.
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
AUC12h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 12 hours post dosing.
Cavg is the average steady-state plasma concentration.
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied (\[Cmax - Cmin\] / Cavg).
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
Ctrough is the observed analyte concentration just prior to the beginning or at the end of a dosing Interval.
C24h is the observed analyte concentration at 24 hours post dosing.
C24h is the observed analyte concentration at 24 hours post dosing.
Cmin is the minimum observed analyte concentration.
Cmin is the minimum observed analyte concentration.
Cmax is the maximum observed analyte concentration.
Cmax is the maximum observed analyte concentration.
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
Tmax is the actual sampling time to reach the maximum observed analyte concentration.
AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
AUC24h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
Cavg average steady-state plasma concentration.
Cavg average steady-state plasma concentration.
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied (\[Cmax - Cmin\] / Cavg).
FI is the percentage fluctuation(variation between maximum and minimum concentration at steady-state), calculated as: 100 multiplied (\[Cmax - Cmin\] / Cavg).
Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of ethinylestradiol.
Ratio Cmax, test/ref is the ratio of individual Cmax values between test and reference treatment of Norethindrone.
Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Ethinylestradiol.
Ratio AUC24h, test/ref is the ratio of individual AUC24h values between test and reference treatment of Norethindrone.
| Arm | Type | Description |
|---|---|---|
| Oral Contraceptive Tablet + JNJ-42847922 | EXPERIMENTAL | All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period). |
| 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). |
| Name | Type | Description |
|---|---|---|
| Ethinyl Estradiol + Levonorgestrel | DRUG | 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. |
| JNJ-42847922 | DRUG | Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2. |
| 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. |
Inclusion Criteria: * Be female of childbearing potential (women with tubal ligation are not accepted) * Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23 within the range of 18 to 30 kilogram / square meter (kg/m\^2) inclusive * Have a systolic blood pressure betw...
Ethinylestradiol is a synthetic estrogen used as a small molecule drug. In the studies listed here it appears as the estrogen component of oral contraceptive combinations, given with levonorgestrel or norethindrone. It is being studied by Johnson & Johnson (JNJ) in Phase 1 clinical development.
Ethinylestradiol targets ESR1, the estrogen receptor 1, and acts as an agonist at that receptor. Binding and activating ESR1 is the mechanism through which the drug exerts its estrogenic activity. ESR1 is the only molecular target identified for this asset in its development program.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of ethinylestradiol. The company is listed as the sponsor of the clinical studies evaluating the drug, including the Phase 1 pharmacokinetic trials conducted in healthy female participants in Belgium.
Ethinylestradiol is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies, and both are completed, with no active trials currently listed. The program has enrolled a total of 42 participants across those two completed studies.
Ethinylestradiol has been studied in two completed Phase 1 trials: NCT03249402, which evaluated the effect of multiple oral doses of JNJ-42847922 on the steady-state pharmacokinetics of an oral contraceptive containing ethinyl estradiol and levonorgestrel, and NCT02652650, which investigated the effect of JNJ-63623872 at steady-state on the pharmacokinetics of ethinylestradiol and norethindrone.