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The main objectives of this study are to determine the effect of elenestinib on the pharmacokinetic parameters (how the drug is absorbed, distributed, and processed by the body) of midazolam, and to determine the effect of elenestinib on the pharmacokinetic parameters of levonorgestrel/ethinyl estradiol, when given as a combined oral contraceptive.
Healthy adult participants will receive midazolam and levonorgestrel/ethinyl estradiol with and without elenestinib and have blood samples taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elenestinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) | Up to 27 days | |
| Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) | Up to 27 days | |
| Percent of AUC0-inf extrapolated (AUC%extrap) | Up to 27 days | |
| Maximum observed concentration (Cmax) | Up to 27 days | |
| Time to reach Cmax (Tmax) | Up to 27 days | |
| Apparent first-order terminal elimination half-life (t1/2) | Up to 27 days | |
| Apparent total plasma clearance after oral administration (CL/F) | Up to 27 days | |
| Apparent volume of distribution during the terminal elimination phase after oral administration (Vz/F) | Up to 27 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | From first dose to date of last dose plus 30 days (up to approximately 7 weeks) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc | Tempe | Arizona | 85282 | United States |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Specified dose on specified days |
|
| Levonorgestrel/Ethinyl Estradiol | Drug | Specified dose on specified days |
|
| D006571 | Heterocyclic Compounds |
| 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 |