A Phase 1 interventional study of Midalozam and Aprocitentan in Healthy Subjects, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other
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.
Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of Midazolam 8 mg on Day 1
Drug: Midalozam
Single dose of ACT-132577 150 mg on Day 2; single dose of ACT-132577 50 mg on Day 3, Day 4, and Day 5.
Drug: Aprocitentan
Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6
Drug: Midalozam · Drug: Aprocitentan
Syrup for oral use
Capsules for oral use
Also known as: ACT-132577
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)
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Idorsia Pharmaceuticals Ltd.