A Food Effect Study of TS-142 in Healthy Subjects

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

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

Conditions
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Effect of Food

Intervention / Treatment
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* Drug: TS-142 10 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |