A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Midalozam; Drug: Aprocitentan

• Registration Number: NCT02841761
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-22
• Primary Completion: 2016-09-01
• Study Completion: 2016-10-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Signed informed consent in the local language prior to any study-mandated procedure
• Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
• Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests

Exclusion Criteria

• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A (Midazolam)	Midalozam	Single dose of Midazolam 8 mg on Day 1
Treatment B2 (Midazolam + ACT-132577)	Midalozam	Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6
Treatment B1 (ACT-132577)	Aprocitentan	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.
Treatment B2 (Midazolam + ACT-132577)	Aprocitentan	Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6

Primary Outcome Measures

Name	Time	Method
Maximum observed plama concentration (Cmax)	Midazolam PK sampling on Days 1, 2, 6 and 7	Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)	Midazolam PK sampling on Days 1, 2, 6 and 7	AUC0-∞ of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Time to reach Cmax (tmax)	Midazolam PK sampling on Days 1, 2, 6 and 7	Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Terminal half-life (t1/2)	Midazolam PK sampling on Days 1, 2, 6 and 7	T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	From Day 1 to Follow-up (for up to 38 days)
Number of subjects with serious adverse events	From Screening to Follow-up (for up to 59 days)

Trial Locations

Locations (1)

Investigator Site; 🇺🇸 Newark, New Jersey, United States