A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects

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

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.

Inclusion Criteria:

• 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 Criteria:

• 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