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The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE) | Experimental | Povorcitinib and LNG/EE will be administered at the protocol defined doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povorcitinib | Drug | Povorcitinib will be administered at protocol defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levonorgestrel (LNG) concentration in plasma | LNG concentration in plasma. | Up to Day 21 |
| Ethinyl estradiol (EE) concentration in plasma | EE concentration in plasma. | Up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment. | Up to Day 32 |
| Additional LNG/EE PK parameters in plasma |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Clinical Research Unit | Tempe | Arizona | 85283 | United States |
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| Levonorgestrel/Ethinyl estradiol | Drug | Levonorgestrel/Ethinyl estradiol will be administered at protocol defined dose. |
|
Additional LNG/EE PK parameters in plasma. |
| Up to Day 21 |
| Povorcitinib concentration in plasma | Povorcitinib concentration in plasma. | Up to Day 21 |
| ID | Term |
|---|---|
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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