A Food Effect Study of TS-142 in Healthy Subjects

A Study to Assess the Food Effect 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

Study Overview

• Status: Completed
• Conditions: Effect of Food
• Intervention / Treatment: Drug: TS-142 10 mg

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Japanese male who are aged 18 years or older but less than 40 years at the time of informed consent
2. Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
3. 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:

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
2. 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
3. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fed condition; Period in which subjects receive a single oral dose of TS-142 tablet in fed condition.	Drug: TS-142 10 mg; Single-dose of 10 mg of TS-142
Experimental: Fasted condition; Period in which subjects receive a single oral dose of TS-142 tablet in fasted condition.	Drug: TS-142 10 mg; Single-dose of 10 mg of TS-142

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: January 22, 2023
• First Submitted That Met QC Criteria: January 22, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TS142-304

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No