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.

NCT04390334 | Completed Phase 1

• 2 other identifiers: ID-078-1202020-000653-27
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 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)

Study Arms (4)

Treatment A: Daridorexant

EXPERIMENTAL

Single dose of 50 mg daridorexant

Drug: Daridorexant

Treatment B: Famotidine & daridorexant

EXPERIMENTAL

Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant

Drug: Daridorexant; Drug: Famotidine

Treatment C: Efavirenz

EXPERIMENTAL

600 mg efavirenz once daily in the evening from Day 5 to Day 14

Drug: Efavirenz

Treatment D: Daridorexant & efavirenz

EXPERIMENTAL

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

Drug: Daridorexant; Drug: Efavirenz

Interventions

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.

Treatment A: Daridorexant; Treatment B: Famotidine & daridorexant; Treatment D: Daridorexant & efavirenz

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.

Treatment B: Famotidine & daridorexant

Efavirenz DRUG

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

Treatment C: Efavirenz; Treatment D: Daridorexant & efavirenz

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

MeSH Terms

Interventions

daridorexant; Famotidine; efavirenz

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials Study Director

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 treatment arms in 2 sequences, ABCD or BACD.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: May 13, 2020
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)