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.

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Idorsia Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Daridorexant
Drug: Famotidine
Drug: Efavirenz

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

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: Famotidine
Drug: Daridorexant
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: Efavirenz
Drug: Daridorexant

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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