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NCT Number: NCT03799978

A Clinical 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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CEPHA s.r.o.

Pilsen, 323 00, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT-541468

Drug

ACT-541468 50 mg film-coated tablets

Primary outcomes

  1. 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

Other outcomes

  1. Pharmacokinetic endpoint: AUC0-inf

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

    AUC from time zero to infinity

  2. Pharmacokinetic endpoint: Cmax

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

    Maximum plasma concentration

  3. Pharmacokinetic endpoint: tmax

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

    Time to reach maximum plasma concentration

  4. Pharmacokinetic endpoint: t½

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

    Terminal elimination half-life

  5. Treatment-emergent adverse events

    Time frame: From study treatment administration up to EOT; duration: up to 48 hours in each treatment period

  6. Serious treatment-emergent adverse events

    Time frame: From study treatment administration up to EOT; duration: up to 48 hours in each treatment period

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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