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Completed

NCT Number: NCT02841761

A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site

Newark, New Jersey, 07103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midalozam

Drug

Syrup for oral use

Aprocitentan

Drug

Capsules for oral use

Other names: ACT-132577

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: From Day 1 to Follow-up (for up to 38 days)

  2. Number of subjects with serious adverse events

    Time frame: From Screening to Follow-up (for up to 59 days)

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2016
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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