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.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04390334

Enrollment

Registered

2020-05-15

Start date

2020-05-13

Completion date

2020-06-26

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGDaridorexant

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

DRUGFamotidine

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

DRUGEfavirenz

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention model description

4 treatment arms in 2 sequences, ABCD or BACD.

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026