This was a 2-part study (Part 1 and Part 2), with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
38
ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
Midazolam was dosed at 2 mg (1 milliliter \[mL\] of a 2 mg/mL syrup).
Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.
Clinical Study Site
Tempe, Arizona, United States
Part 1: Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
Time frame: Up to 24 hours postdose
Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
Time frame: Up to 24 hours postdose
Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
Time frame: Up to 24 hours postdose
Part 1: AUC0-inf Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
Time frame: Up to 168 hours postdose
Part 1: Cmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
Time frame: Up to 168 hours postdose
Part 1: Tmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
Time frame: Up to 168 hours postdose
Part 2: AUC0-inf Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
Time frame: Up to 96 hours postdose
Part 2: Cmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
Time frame: Up to 96 hours postdose
Part 2: Tmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
Time frame: Up to 96 hours postdose
Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Midazolam
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Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Part 1: Number Of Participants With TEAEs After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Digoxin
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Part 2: Number Of Participants With TEAEs After A Single Dose Of ACH-0145228 Coadministered With Multiple Doses Of Itraconazole
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)