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

Healthy Subjects Clinical Trial

Official title:

A Single-center, Open-label, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841761
• Other study ID #: AC-080-103
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2016
• Est. completion date: October 1, 2016

Study information

• Verified date: November 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Midalozam
Syrup for oral use
• Aprocitentan
Capsules for oral use

Locations

Country	Name	City	State
United States	Investigator Site	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plama concentration (Cmax)	Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577	Midazolam PK sampling on Days 1, 2, 6 and 7
Primary	Area under the plasma concentration-time curve from zero to infinity (AUC0-8)	AUC0-8 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577	Midazolam PK sampling on Days 1, 2, 6 and 7
Primary	Time to reach Cmax (tmax)	Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577	Midazolam PK sampling on Days 1, 2, 6 and 7
Primary	Terminal half-life (t1/2)	T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577	Midazolam PK sampling on Days 1, 2, 6 and 7
Secondary	Number of subjects with adverse events		From Day 1 to Follow-up (for up to 38 days)
Secondary	Number of subjects with serious adverse events		From Screening to Follow-up (for up to 59 days)