MedTrace Logo

A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects

NCT05480488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-11-08

No results posted yet for this study

Summary

A study to examine the effect of daridorexant on the way the body absorbs, distributes, and gets rid of midazolam and warfarin in healthy male subjects

Conditions

  • Healthy

Interventions

DRUG

Midazolam

Subjects will receive a single oral dose of 2 mg midazolam (Treatment A, B, and C).

DRUG

Warfarin

Subjects will receive a single oral dose of 25 mg warfarin (Treatment A and B).

DRUG

Daridorexant

Subjects will receive an o.d. oral dose of 50 mg daridorexant from Day 1 to Day 7 of Treatment B and a single oral dose of 50 mg daridorexant on Day 1 of Treatment C.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idosia Pharmaceuticals Ltd

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2022-09-23
Completion
2022-10-06
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480488 on ClinicalTrials.gov