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.
NCT ID: NCT04390334
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2020-05-13
2020-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Treatment A: Daridorexant
Single dose of 50 mg daridorexant
Daridorexant
Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.
Treatment B: Famotidine & daridorexant
Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant
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.
Treatment C: Efavirenz
600 mg efavirenz once daily in the evening from Day 5 to Day 14
Efavirenz
Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.
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
Daridorexant
Daridorexant will be administered orally as 1 film-coated tablet of 50 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Healthy male subjects aged between 18 and 45 years (inclusive) at Screening.
Exclusion Criteria
* 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials Study Director
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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CRS Clinical Research Services Mannheim GmbH
Mannheim, , Germany
Countries
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Other Identifiers
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2020-000653-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ID-078-120
Identifier Type: -
Identifier Source: org_study_id
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