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.

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390334
• Other study ID #: ID-078-120
• Secondary ID: 2020-000653-27
• Status: Completed
• Phase: Phase 1
• Start date: May 13, 2020
• Est. completion date: June 26, 2020

Study information

• Verified date: September 2020
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Daridorexant
Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.
• Famotidine
Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.
• Efavirenz
Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Mannheim GmbH	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter of daridorexant: Maximum plasma concentration (Cmax)		Various time points during Treatment A through D (Total duration: up to 3 weeks).
Primary	PK parameter of daridorexant: Time to reach Cmax (tmax)		Various time points during Treatment A through D (Total duration: up to 3 weeks).
Primary	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).
Primary	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).
Primary	PK parameter of daridorexant: Terminal elimination half-life (t½)		Various time points during Treatment A through D (Total duration: up to 3 weeks).
Secondary	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)