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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Daridorexant; Drug: Famotidine; Drug: Efavirenz

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • CRS Clinical Research Services Mannheim GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: Daridorexant; Single dose of 50 mg daridorexant	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.
Experimental: Treatment B: Famotidine & daridorexant; Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant	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.; Drug: Famotidine; Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.
Experimental: Treatment C: Efavirenz; 600 mg efavirenz once daily in the evening from Day 5 to Day 14	Drug: Efavirenz; Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.
Experimental: Treatment D: Daridorexant & efavirenz; 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; Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.; Drug: Efavirenz; Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Investigators: Study Director: Clinical Trials Study Director, Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Anti-Ulcer Agents; Cytochrome P-450 CYP3A Inducers; Histamine Antagonists; Histamine Agents; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Histamine H2 Antagonists; Cytochrome P-450 CYP2C19 Inhibitors; Famotidine; Efavirenz
• Other Study ID Numbers: ID-078-120; 2020-000653-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No