Healthy
Conditions
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.
Interventions
DRUGACT-541468
ACT-541468 50 mg film-coated tablets
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Two way crossover
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic endpoint: AUC0-24 | Multiple timepoints; duration: up to 48 hours in each treatment period | Area under the plasma concentration-time curve (AUC) from time zero to 24 h |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic endpoint: Cmax | Multiple timepoints; duration: up to 48 hours in each treatment period | Maximum plasma concentration |
| Pharmacokinetic endpoint: tmax | Multiple timepoints; duration: up to 48 hours in each treatment period | Time to reach maximum plasma concentration |
| Pharmacokinetic endpoint: AUC0-inf | Multiple timepoints; duration: up to 48 hours in each treatment period | AUC from time zero to infinity |
| Treatment-emergent adverse events | From study treatment administration up to EOT; duration: up to 48 hours in each treatment period | — |
| Serious treatment-emergent adverse events | From study treatment administration up to EOT; duration: up to 48 hours in each treatment period | — |
| Pharmacokinetic endpoint: t½ | Multiple timepoints; duration: up to 48 hours in each treatment period | Terminal elimination half-life |
Countries
Czechia
Outcome results
None listed