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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ACT-541468

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Pilsen, Czechia, 323 00
    • CEPHA s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: ACT-541468 50 mg under fasted conditions; Single oral dose administered on Day 1 under fasted conditions.	Drug: ACT-541468; ACT-541468 50 mg film-coated tablets
Experimental: Treatment B: ACT-541468 50 mg under fed conditions; Single oral dose administered on Day 1 administered after food intake.	Drug: ACT-541468; ACT-541468 50 mg film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic endpoint: AUC0-24	Area under the plasma concentration-time curve (AUC) from time zero to 24 h	Multiple timepoints; duration: up to 48 hours in each treatment period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic endpoint: AUC0-inf	AUC from time zero to infinity	Multiple timepoints; duration: up to 48 hours in each treatment period
Pharmacokinetic endpoint: Cmax	Maximum plasma concentration	Multiple timepoints; duration: up to 48 hours in each treatment period
Pharmacokinetic endpoint: tmax	Time to reach maximum plasma concentration	Multiple timepoints; duration: up to 48 hours in each treatment period
Pharmacokinetic endpoint: t½	Terminal elimination half-life	Multiple timepoints; duration: up to 48 hours in each treatment period
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

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2019
• Primary Completion (Actual): March 18, 2019
• Study Completion (Actual): March 18, 2019

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ID-078-113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No