Study to determine the effect of multiple-dose BBT-877 on the single-dose pharmacokinetics of midazolam, the safety and tolerability of a single dose of BBT-877 administered alone and with multiple doses of itraconazole, and the effect of multiple-dose esomeprazole on the single-dose pharmacokinetics of BBT-877, in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
BBT-877 oral capsule.
Midazolam oral syrup.
Itraconazole oral capsule.
Celerion
Lincoln, Nebraska, United States
AUC (the area under the curve) [Pharmacokinetics]
AUC for midazolam and 1-OH-midazolam with and without BBT-877 (Arm 1), and for BBT-877 with and without itraconazole (Arm 2) or esomeprazole (Arm 3)
Time frame: Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2
Cmax (peak concentration) [Pharmacokinetics]
Cmax for midazolam and 1-OH-midazolam with and without BBT-877 (Arm 1), and for BBT-877 with and without itraconazole (Arm 2) or esomeprazole (Arm 3)
Time frame: Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2
Plasma LPA (Lysophosphatidic acid) concentration [Pharmacodynamics (Arm 2 and 3)]
plasma LPA (18:2 and 20:4) concentrations over time and percent decrease from baseline LPA level
Time frame: Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2
Incidence of adverse events [Safety and tolerability]
Incidence of adverse events
Time frame: Up to 14 days after the last study drug administration
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Esomeprazole oral capsule.