NCT03799978
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- ACT-541468
- Conditions
- Healthy
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic endpoint: AUC0-24
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment A: ACT-541468 50 mg under fasted conditions
Single oral dose administered on Day 1 under fasted conditions.
Intervention: ACT-541468
Treatment B: ACT-541468 50 mg under fed conditions
Single oral dose administered on Day 1 administered after food intake.
Intervention: ACT-541468
Outcomes
Primary Outcomes
Pharmacokinetic endpoint: AUC0-24
Time Frame: 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
Study Sites (1)
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