The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Syrup for oral use
Capsules for oral use
Investigator Site
Newark, New Jersey, United States
Maximum observed plama concentration (Cmax)
Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Time frame: Midazolam PK sampling on Days 1, 2, 6 and 7
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
AUC0-∞ of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Time frame: Midazolam PK sampling on Days 1, 2, 6 and 7
Time to reach Cmax (tmax)
Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Time frame: Midazolam PK sampling on Days 1, 2, 6 and 7
Terminal half-life (t1/2)
T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Time frame: Midazolam PK sampling on Days 1, 2, 6 and 7
Number of subjects with adverse events
Time frame: From Day 1 to Follow-up (for up to 38 days)
Number of subjects with serious adverse events
Time frame: From Screening to Follow-up (for up to 59 days)
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