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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Celerion, Inc
Tempe, Arizona, United States
RECRUITINGArea under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t)
Time frame: Up to 27 days
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Up to 27 days
Percent of AUC0-inf extrapolated (AUC%extrap)
Time frame: Up to 27 days
Maximum observed concentration (Cmax)
Time frame: Up to 27 days
Time to reach Cmax (Tmax)
Time frame: Up to 27 days
Apparent first-order terminal elimination half-life (t1/2)
Time frame: Up to 27 days
Apparent total plasma clearance after oral administration (CL/F)
Time frame: Up to 27 days
Apparent volume of distribution during the terminal elimination phase after oral administration (Vz/F)
Time frame: Up to 27 days
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From first dose to date of last dose plus 30 days (up to approximately 7 weeks)
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