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.

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Famotidine; Drug: Efavirenz; Drug: Daridorexant

Study type: Interventional

Funder types: Industry

Identifiers

NCT04390334

ID-078-120

2020-000653-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Treatment A: Daridorexant

Experimental group

Description:

Single dose of 50 mg daridorexant

Treatment:

Drug: Daridorexant

Treatment B: Famotidine & daridorexant

Experimental group

Description:

Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant

Treatment:

Drug: Daridorexant

Drug: Famotidine

Treatment C: Efavirenz

Experimental group

Description:

600 mg efavirenz once daily in the evening from Day 5 to Day 14

Treatment:

Drug: Efavirenz

Treatment D: Daridorexant & efavirenz

Experimental group

Description:

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

Treatment:

Drug: Daridorexant

Drug: Efavirenz