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

NCT02841761 | Completed Phase 1

• 1 other identifier: AC-080-103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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

• Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)

  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)

  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)

  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 Outcomes (2)

• Number of subjects with adverse events

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

• Number of subjects with serious adverse events

  From Screening to Follow-up (for up to 59 days)

Study Arms (3)

Treatment A (Midazolam)

EXPERIMENTAL

Single dose of Midazolam 8 mg on Day 1

Drug: Midalozam

Treatment B1 (ACT-132577)

EXPERIMENTAL

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

Treatment B2 (Midazolam + ACT-132577)

EXPERIMENTAL

Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6

Drug: Midalozam; Drug: Aprocitentan

Interventions

Midalozam DRUG

Syrup for oral use

Treatment A (Midazolam); Treatment B2 (Midazolam + ACT-132577)

Aprocitentan DRUG

Capsules for oral use

Also known as: ACT-132577

Treatment B1 (ACT-132577); Treatment B2 (Midazolam + ACT-132577)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Investigator Site

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Interventions

aprocitentan

Study Officials

• Clinical Trial

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

US (1)