A Food Effect Study of TS-142 in Healthy Subjects

NCT05707897 | Completed Phase 1

• 1 other identifier: TS142-304
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Effect of Food

Outcome Measures

Primary Outcomes (9)

• Plasma concentration

  Plasma concentration of unchanged form and its metabolite

  Predose and up to 24 hours postdose

• Pharmacokinetic parameters

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

  Predose and up to 24 hours postdose

• Pharmacokinetic parameters

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

  Predose and up to 24 hours postdose

• Pharmacokinetic parameters

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

  Predose and up to 24 hours postdose

• Pharmacokinetic parameters

  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)

  Predose and up to 24 hours postdose

• Pharmacokinetic parameters

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

  Predose and up to 24 hours postdose

• Pharmacokinetic parameters

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

  Predose and up to 24 hours postdose

• Pharmacokinetic parameters

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

  Predose and up to 24 hours postdose

• Pharmacokinetic parameters

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

  Predose and up to 24 hours postdose

Study Arms (2)

Fed condition

EXPERIMENTAL

Period in which subjects receive a single oral dose of TS-142 tablet in fed condition.

Drug: TS-142 10 mg

Fasted condition

EXPERIMENTAL

Period in which subjects receive a single oral dose of TS-142 tablet in fasted condition.

Drug: TS-142 10 mg

Interventions

TS-142 10 mg DRUG

Single-dose of 10 mg of TS-142

Fasted condition; Fed condition

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

TS-142

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: February 1, 2023
• Study Start: February 15, 2023
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: February 28, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)