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Completed

NCT Number: NCT05707897

A Food Effect Study of TS-142 in Healthy Subjects

This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy subjects

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Key information

Conditions

Effect of Food

Age range

18 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese male who are aged 18 years or older but less than 40 years at the time of informed consent
  • Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
  • Subjects who are judged by the investigators as an eligible for the clinical trial participation based on the screening tests and the tests conducted at treatment period 1.

Other protocol defined inclusion criteria could apply.

Exclusion criteria

  • Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
  • Subjects who have any unsuitable medical history for participation in this study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
  • Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts

Other protocol defined exclusion criteria could apply.

Treatment and study plan

TS-142 10 mg

Drug

Single-dose of 10 mg of TS-142

Primary outcomes

  1. Plasma concentration

    Time frame: Predose and up to 24 hours postdose

    Plasma concentration of unchanged form and its metabolite

  2. Pharmacokinetic parameters

    Time frame: Predose and up to 24 hours postdose

    Maximum plasma concentration of unchanged form and its metabolite (Cmax)

  3. Pharmacokinetic parameters

    Time frame: Predose and up to 24 hours postdose

    Time to maximum plasma concentration of unchanged form and its metabolite (tmax)

  4. Pharmacokinetic parameters

    Time frame: Predose and up to 24 hours postdose

    Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)

  5. Pharmacokinetic parameters

    Time frame: Predose and up to 24 hours postdose

    Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of unchanged form and its metabolite (AUC0-last)

  6. Pharmacokinetic parameters

    Time frame: Predose and up to 24 hours postdose

    Terminal elimination rate constant of unchanged form and its metabolite (λz)

  7. Pharmacokinetic parameters

    Time frame: Predose and up to 24 hours postdose

    Elimination half-life of unchanged form and its metabolite (t1/2)

  8. Pharmacokinetic parameters

    Time frame: Predose and up to 24 hours postdose

    Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)

  9. Pharmacokinetic parameters

    Time frame: Predose and up to 24 hours postdose

    Apparent total body clearance of unchanged form (CL/F)

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Study to Assess the Food Effect of TS-142 in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2023
Registry last updated
Feb 28, 2025

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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