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.

Sponsor

Idorsia Pharmaceuticals Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04390334

Collaborator

(none)

Enrollment

Location

Arms

1.4

Actual Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Daridorexant Drug: Famotidine Drug: Efavirenz	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

4 treatment arms in 2 sequences, ABCD or BACD.4 treatment arms in 2 sequences, ABCD or BACD.

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

May 13, 2020

Actual Primary Completion Date :

Jun 26, 2020

Actual Study Completion Date :

Jun 26, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical Research Services Mannheim GmbH	Mannheim		Germany	68167

Sponsors and Collaborators

Idorsia Pharmaceuticals Ltd.

Investigators

Study Director: Clinical Trials Study Director, Idorsia Pharmaceuticals Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Idorsia Pharmaceuticals Ltd.

ClinicalTrials.gov Identifier:

NCT04390334

Other Study ID Numbers:

ID-078-120
2020-000653-27

First Posted:

May 15, 2020

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Efavirenz

Famotidine

Study Results

No Results Posted as of Sep 16, 2020