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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05480488
Other study ID # ID-078-126
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 23, 2022
Est. completion date October 6, 2022

Study information

Verified date November 2022
Source Idorsia Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 6, 2022
Est. primary completion date September 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. - Healthy male subject aged between 18 and 45 years (inclusive) at Screening. Exclusion Criteria: - Known hypersensitivity to daridorexant, midazolam, warfarin, or treatments of the same class, or any of their excipients. - Any history of hemorrhagic disease, whether or not hereditary. - Any history of complications with bleeding after surgery or tooth extractions and/or frequent nasal, hemorrhoidal, or gingival bleeding. - Activated partial thromboplastin time (aPTT) > 40 sec and/or international normalized ratio (INR) > 1.15 at Screening. - Platelet count < 150 or >400 x 10^9/L at Screening. - Clinically relevant findings on the physical examination at Screening. - Clinically relevant abnormalities on 12-lead ECG, measured after 5 min in the supine position at Screening. - Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry) at Screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Midazolam
Subjects will receive a single oral dose of 2 mg midazolam (Treatment A, B, and C).
Warfarin
Subjects will receive a single oral dose of 25 mg warfarin (Treatment A and B).
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.

Locations

Country Name City State
Germany Nuvisan GmbH Neu-Ulm

Sponsors (1)

Lead Sponsor Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum concentration (Cmax) of midazolam and its metabolite 1-OH midazolam Blood samples for pharmacokinetic analyses of midazolam will be taken at various time points from Day 1 to 2 of Treatment Period A, from Day 1 to 2 of Treatment Period B, and from Day 1 to 2 of Treatment Period C (total duration: 6 days).
Primary Cmax of S-warfarin Blood samples for pharmacokinetic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days).
Primary Time to reach Cmax (tmax) of midazolam and 1-OH midazolam Blood samples for pharmacokinetic analyses of midazolam will be taken at various time points from Day 1 to 2 of Treatment Period A, from Day 1 to 2 of Treatment Period B, and from Day 1 to 2 of Treatment Period C (total duration: 6 days).
Primary Tmax of S-warfarin Blood samples for pharmacokinetic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days).
Primary Area under the concentration-time curve (AUC) from zero to infinity (AUC0-8) of midazolam and 1-OH midazolam Blood samples for pharmacokinetic analyses of midazolam will be taken at various time points from Day 1 to 2 of Treatment Period A, from Day 1 to 2 of Treatment Period B, and from Day 1 to 2 of Treatment Period C (total duration: 6 days)
Primary AUC0-8 of S-warfarin Blood samples for pharmacokinetic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days).
Primary Terminal elimination half-life (t½) of midazolam and 1-OH midazolam Blood samples for pharmacokinetic analyses of midazolam will be taken at various time points from Day 1 to 2 of Treatment Period A, from Day 1 to 2 of Treatment Period B, and from Day 1 to 2 of Treatment Period C (total duration: 6 days).
Primary T½ of S-warfarin Blood samples for pharmacokinetic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days).
Secondary AUC0-144 for international normalized ratio (AUC INR) Blood samples for pharmacodynamic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days)
Secondary The maximum effect on INR (INRmax) Blood samples for pharmacodynamic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days)
Secondary Time to reach maximum effect of INR (t Emax) Blood samples for pharmacodynamic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days)
Secondary AUC0-144 for Factor VII (AUC VII) Blood samples for pharmacodynamic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days)
Secondary The maximum effect on Factor VII (VIImax) Blood samples for pharmacodynamic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days)
Secondary Time to reach maximum effect of Factor VII (t Emax) Blood samples for pharmacodynamic analyses of S-warfarin will be taken at various time points from Day 1 to 7 of Treatment Period A and from Day 1 to 7 of Treatment Period B (total duration: 14 days)
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