This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Celerion
Tempe, Arizona, United States
Area under the plasma concentration time curve (AUC) of ABI-H2158
Time frame: before dosing and at pre-specified time points up to Day 17
Maximum observed plasma concentration (Cmax) of ABI-H2158
Time frame: before dosing and at pre-specified time points up to Day 17
AUC of Midazolam
Time frame: before dosing and at pre-specified time points up to Day 12
Cmax of Midazolam
Time frame: before dosing and at pre-specified time points up to Day 17
AUC of ethinyl estradiol and levonorgestrel
Time frame: before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days
Cmax of ethinyl estradiol and levonorgestrel
Time frame: before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Midazolam syrup
Ethinyl Estradiol / Levonorgestrel tablets
Esomeprazole capsules
Placebo matching Ethinyl Estradiol / Levonorgestrel tablets