A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
NCT ID: NCT03799978
Last Updated: 2019-04-12
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
20 participants
INTERVENTIONAL
2019-03-09
2019-03-18
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: ACT-541468 50 mg under fasted conditions
Single oral dose administered on Day 1 under fasted conditions.
ACT-541468
ACT-541468 50 mg film-coated tablets
Treatment B: ACT-541468 50 mg under fed conditions
Single oral dose administered on Day 1 administered after food intake.
ACT-541468
ACT-541468 50 mg film-coated tablets
Interventions
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ACT-541468
ACT-541468 50 mg film-coated tablets
Eligibility Criteria
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Inclusion Criteria
* Healthy male subjects aged between 18 and 45 years (inclusive) at Screening
* Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
* No clinically relevant findings on the physical examination at Screening
Exclusion Criteria
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
* Modified Swiss Narcolepsy Scale total score \< 0 at screening or history of narcolepsy or cataplexy
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
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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CEPHA s.r.o.
Pilsen, , Czechia
Countries
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Other Identifiers
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ID-078-113
Identifier Type: -
Identifier Source: org_study_id
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