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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ACT-541468

Study type: Interventional

Funder types: Industry

Identifiers

NCT03799978

ID-078-113

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment A: ACT-541468 50 mg under fasted conditions

Experimental group

Description:

Single oral dose administered on Day 1 under fasted conditions.

Treatment:

Drug: ACT-541468

Treatment B: ACT-541468 50 mg under fed conditions

Experimental group

Description:

Single oral dose administered on Day 1 administered after food intake.

Treatment:

Drug: ACT-541468