ClinicalTrials.Veeva

Menu

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

Idorsia Pharmaceuticals logo

Idorsia Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Aprocitentan
Drug: Midalozam

Study type

Interventional

Funder types

Industry

Identifiers

NCT02841761
AC-080-103

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 3 patient groups

Treatment A (Midazolam)
Experimental group
Description:
Single dose of Midazolam 8 mg on Day 1
Treatment:
Drug: Midalozam
Treatment B1 (ACT-132577)
Experimental group
Description:
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:
Drug: Aprocitentan
Treatment B2 (Midazolam + ACT-132577)
Experimental group
Description:
Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6
Treatment:
Drug: Midalozam
Drug: Aprocitentan

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems