A Food Effect Study of TS-142 in Healthy Subjects

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Effect of Food

Treatments: Drug: TS-142 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05707897

TS142-304

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Fed condition

Experimental group

Description:

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

Treatment:

Drug: TS-142 10 mg

Fasted condition

Experimental group

Description:

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

Treatment:

Drug: TS-142 10 mg