A Food Effect Study of TS-142 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-03-20

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

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Detailed Description

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Conditions

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Effect of Food

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fed condition

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

Group Type EXPERIMENTAL

TS-142 10 mg

Intervention Type DRUG

Single-dose of 10 mg of TS-142

Fasted condition

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

Group Type EXPERIMENTAL

TS-142 10 mg

Intervention Type DRUG

Single-dose of 10 mg of TS-142

Interventions

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TS-142 10 mg

Single-dose of 10 mg of TS-142

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes