A Food Effect Study of TS-142 in Healthy Subjects

Phase 1

Completed

• Conditions: Effect of Food
• Interventions: Drug: TS-142 10 mg

• Registration Number: NCT05707897
• Lead 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-22
• Study First Submitted QC: 2023-01-22
• Study First Posted: 2023-02-01
• Study Start: 2023-02-15
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fed condition	TS-142 10 mg	Period in which subjects receive a single oral dose of TS-142 tablet in fed condition.
Fasted condition	TS-142 10 mg	Period in which subjects receive a single oral dose of TS-142 tablet in fasted condition.

Primary Outcome Measures

Name	Time	Method
Plasma concentration	Predose and up to 24 hours postdose	Plasma concentration of unchanged form and its metabolite
Pharmacokinetic parameters	Predose and up to 24 hours postdose	Apparent total body clearance of unchanged form (CL/F)

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan