A Phase 1 interventional study of Midazolam and ACT-541468 in Healthy Subjects, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-10.
Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other
The main objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics (i.e. how long and how much a compound is present in the blood) of ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam, a CYP3A4 substrate.
Food effect will be assessed by comparing the pharmacokinetic (PK) parameters of a single dose of ACT-541468 under fasted (Treatment B) and fed (Treatment C) conditions.
Potential CYP3A4 inhibiting / inducing effects of ACT-541468 will be assessed by comparing the PK parameters of midazolam alone (Treatment A) and midazolam given with a single dose of ACT-541468 (Treatment B) or with multiple doses of ACT-541468 (Treatment D).
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:
Treatments will be given to all subjects in the same fixed sequence: Treatment A (Day 1, single dose of midazolam, fasted), Treatment B (Day 2, single dose of ACT-541468 followed by single dose of midazolam, fasted), Treatment C (Day 4, single dose ACT-541468, fed), Treatment D (multiple doses of ACT-541468 from Day 5 to Day 8 + single dose of midazolam on Day 8, fasted).
Drug: Midazolam · Drug: ACT-541468
2 mg/mL oral solution
Hard gelatin capsules for oral use at a strength of 25 mg
Maximum plasma concentration (Cmax) of ACT-541468
Cmax is directly determined from the plasma concentrations-time curves of ACT-541468
Time frame: PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only
Time to reach Cmax (tmax) of ACT-541468
Tmax is directly determined from the plasma concentrations-time curves of ACT-541468
Time frame: PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only
Area under the plasma concentration-time curve [AUC(0-24)] of ACT-541468
AUC is calculated from time zero to 24 hours post dose
Time frame: PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only
Terminal half-life (t1/2) of ACT-541468
t1/2 is calculated from the plasma concentrations-time curves of ACT-541468
Time frame: PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only
Maximum plasma concentration (Cmax) of midazolam
Cmax is directly obtained from the plasma concentrations-time curves of midazolam
Time frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose
Time to reach Cmax (tmax) of midazolam
Tmax is directly obtained from the plasma concentrations-time curves of midazolam
Time frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose
Area under the plasma concentration-time curve [AUC(0-24)] of midazolam
AUC is calculated from time zero to 24 hours post dose
Time frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose
Terminal half-life (t1/2) of midazolam
t1/2 is calculated from the plasma concentrations-time curves of midazolam
Time frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose
Maximum plasma concentration (Cmax) of 1-hydroxymidazolam
Cmax is directly determined from the plasma concentrations-time curves of 1-hydroxymidazolam
Time frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose
Time to reach Cmax (tmax) of 1-hydroxymidazolam
Tmax is directly determined from the plasma concentrations-time curves of 1-hydroxymidazolam
Time frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose
Area under the plasma concentration-time curve [AUC(0-24)] of 1-hydroxymidazolam
AUC is calculated from time zero to 24 hours post dose
Time frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose
Terminal half-life (t1/2) of 1-hydroxymidazolam
t1/2 is calculated from the plasma concentrations-time curves of 1-hydroxymidazolam
Time frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose
Number of subjects with treatment-emergent adverse events and serious adverse events
Time frame: From baseline to end-of-study, i.e.,maximum 5 days after Day 8
Maximum plasma concentration (Cmax) of ACT-541468 metabolites
Time frame: PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose
Time to reach Cmax (tmax) of ACT-541468 metabolites
Time frame: PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose
Area under the plasma concentration-time curve [AUC(0-24)] of ACT-541468 metabolites
Time frame: PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose
Terminal half-life (t1/2) of ACT-541468 metabolites
Time frame: PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Idorsia Pharmaceuticals Ltd.