Clinical trial 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.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4 treatment arms in 2 sequences, ABCD or BACD.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: PK parameter of daridorexant: Maximum plasma concentration (Cmax)
timeFrame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
measure: PK parameter of daridorexant: Time to reach Cmax (tmax)
timeFrame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
measure: PK parameter of daridorexant: AUC from zero to infinity (AUC0-inf)
timeFrame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
measure: PK parameter of daridorexant: AUC from zero to 48 hours (AUC0-48)
timeFrame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
measure: PK parameter of daridorexant: Terminal elimination half-life (t½)
timeFrame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
Secondary outcomes:
measure: Treatment-emergent (S)AEs
timeFrame: Up to EOP for each of the Periods 1 to 3 and up to EOS for Period 4 (Total duration: up to 3 months)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials Study Director
role: STUDY_DIRECTOR
References: