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

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)

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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