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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-09-16

No results posted yet for this study

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

Interventions

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.

DRUG

Efavirenz

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

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials Study Director · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-13
Primary Completion
2020-06-26
Completion
2020-06-26

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390334 on ClinicalTrials.gov