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

November 22, 2022 updated by: Idorsia Pharmaceuticals Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Investigator site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A (Midazolam)
Single dose of Midazolam 8 mg on Day 1
Drug: Midalozam
Syrup for oral use
Experimental: Treatment B1 (ACT-132577)
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
Capsules for oral use
Other Names:
  • ACT-132577
Experimental: Treatment B2 (Midazolam + ACT-132577)
Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6
Drug: Midalozam
Syrup for oral use
Drug: Aprocitentan
Capsules for oral use
Other Names:
  • ACT-132577

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plama concentration (Cmax)
Time Frame: 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
Midazolam PK sampling on Days 1, 2, 6 and 7
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
Time Frame: 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
Midazolam PK sampling on Days 1, 2, 6 and 7
Time to reach Cmax (tmax)
Time Frame: 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
Midazolam PK sampling on Days 1, 2, 6 and 7
Terminal half-life (t1/2)
Time Frame: 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
Midazolam PK sampling on Days 1, 2, 6 and 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events
Time Frame: From Day 1 to Follow-up (for up to 38 days)
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)
From Screening to Follow-up (for up to 59 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idorsia Pharmaceuticals Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • AC-080-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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