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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ACT-541468

• Registration Number: NCT03799978
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-10
• Study Start: 2019-03-09
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: ACT-541468 50 mg under fasted conditions	ACT-541468	Single oral dose administered on Day 1 under fasted conditions.
Treatment B: ACT-541468 50 mg under fed conditions	ACT-541468	Single oral dose administered on Day 1 administered after food intake.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CEPHA s.r.o.; 🇨🇿 Pilsen, Czechia