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Completed

NCT Number: NCT04390334

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.

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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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daridorexant

Drug

Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.

Famotidine

Drug

Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.

Efavirenz

Drug

Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.

Primary outcomes

  1. PK parameter of daridorexant: Maximum plasma concentration (Cmax)

    Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).

  2. PK parameter of daridorexant: Time to reach Cmax (tmax)

    Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).

  3. PK parameter of daridorexant: AUC from zero to infinity (AUC0-inf)

    Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).

  4. PK parameter of daridorexant: AUC from zero to 48 hours (AUC0-48)

    Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).

  5. PK parameter of daridorexant: Terminal elimination half-life (t½)

    Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).

Secondary outcomes

  1. Treatment-emergent (S)AEs

    Time frame: Up to EOP for each of the Periods 1 to 3 and up to EOS for Period 4 (Total duration: up to 3 months)

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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