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NCT05707897 | Completed | Effect of Food

A Food Effect Study of TS-142 in Healthy Subjects
Sponsor:

Taisho Pharmaceutical Co., Ltd.

Brief Summary:

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

Condition or disease

Effect of Food

Intervention/treatment

TS-142 10 mg

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 12 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Study to Assess the Food Effect of TS-142 in Healthy Subjects
Actual Study Start Date : February 15, 2023
Estimated Primary Completion Date : March 20, 2023
Estimated Study Completion Date : March 20, 2023
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

Experimental: Fasted condition

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

Drug: TS-142 10 mg
Ages Eligible for Study: 18 Years to 39 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.
A Food Effect Study of TS-142 in Healthy Subjects

Location Details

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A Food Effect Study of TS-142 in Healthy Subjects

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Japan,

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan,