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

NCT03799978 | Completed Phase 1 FDA Drug

• 1 other identifier: ID-078-113
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pharmacokinetic endpoint: AUC0-inf

  Multiple timepoints; duration: up to 48 hours in each treatment period

• Pharmacokinetic endpoint: Cmax

  Multiple timepoints; duration: up to 48 hours in each treatment period

• Pharmacokinetic endpoint: tmax

  Multiple timepoints; duration: up to 48 hours in each treatment period

Study Arms (2)

Treatment A: ACT-541468 50 mg under fasted conditions

EXPERIMENTAL

Single oral dose administered on Day 1 under fasted conditions.

Drug: ACT-541468

Treatment B: ACT-541468 50 mg under fed conditions

EXPERIMENTAL

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

Drug: ACT-541468

Interventions

ACT-541468 DRUG

ACT-541468 50 mg film-coated tablets

Treatment A: ACT-541468 50 mg under fasted conditions; Treatment B: ACT-541468 50 mg under fed conditions

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

CEPHA s.r.o.

Pilsen, 323 00, Czechia

Location

MeSH Terms

Interventions

daridorexant

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two way crossover

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: March 9, 2019
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)