Status:
COMPLETED
A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study-mandated procedure
- 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
- 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 treatments (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
- Modified Swiss Narcolepsy Scale total score \< 0 at screening or history of narcolepsy or cataplexy
Key Trial Info
Start Date :
March 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03799978
Start Date
March 9 2019
End Date
March 18 2019
Last Update
April 12 2019
Active Locations (1)
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1
CEPHA s.r.o.
Pilsen, Czechia, 323 00