A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.

Study Overview
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Brief Summary
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A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant.

Official Title
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Single-center, Randomized, Open-label Study to Investigate the Effect of Single-dose Famotidine and Multiple-dose Efavirenz on the Pharmacokinetics of Daridorexant in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Daridorexant
* Drug: Famotidine
* Drug: Efavirenz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. Healthy male subjects aged between 18 and 45 years (inclusive) at Screening. Exclusion Criteria: Clinically relevant findings on the physical examination at Screening. Clinically relevant abnormalities on 12-lead ECG, measured after at least 5 min in a supine position at Screening. Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry) at Screening and on Day -1. History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed). Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. Moderate or severe renal insufficiency (creatinine clearance < 60 mL/min calculated with the Cockcroft Gault formula) at Screening. Total bilirubin > 1.5 x Upper Limit of Normal at Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 4 treatment arms in 2 sequences, ABCD or BACD.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: Daridorexant<br>Single dose of 50 mg daridorexant | Drug: Daridorexant<br>* Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.<br>|
| Experimental: Treatment B: Famotidine & daridorexant<br>Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant | Drug: Daridorexant<br>* Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.<br>Drug: Famotidine<br>* Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.<br>|
| Experimental: Treatment C: Efavirenz<br>600 mg efavirenz once daily in the evening from Day 5 to Day 14 | Drug: Efavirenz<br>* Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.<br>|
| Experimental: Treatment D: Daridorexant & efavirenz<br>Single dose of 50 mg daridorexant in the morning of Day 15 followed by a single dose of 600 mg efavirenz in the evening of Days 15 and 16 | Drug: Daridorexant<br>* Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.<br>Drug: Efavirenz<br>* Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter of daridorexant: Maximum plasma concentration (Cmax) |  | Various time points during Treatment A through D (Total duration: up to 3 weeks). | 
| PK parameter of daridorexant: Time to reach Cmax (tmax) |  | Various time points during Treatment A through D (Total duration: up to 3 weeks). | 
| PK parameter of daridorexant: AUC from zero to infinity (AUC0-inf) |  | Various time points during Treatment A through D (Total duration: up to 3 weeks). | 
| PK parameter of daridorexant: AUC from zero to 48 hours (AUC0-48) |  | Various time points during Treatment A through D (Total duration: up to 3 weeks). | 
| PK parameter of daridorexant: Terminal elimination half-life (t½) |  | Various time points during Treatment A through D (Total duration: up to 3 weeks). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent (S)AEs |  | Up to EOP for each of the Periods 1 to 3 and up to EOS for Period 4 (Total duration: up to 3 months) |