CompletedNCT05707897Updated Feb 28, 2025

A Food Effect Study of TS-142 in Healthy Subjects

A Phase 1 interventional study of TS-142 10 mg in Effect of Food, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 39 Years
Sex: Male

Study summary

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

Conditions studied

Effect of Food

In context

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 41 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 39 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

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

Interventions

DrugTS-142 10 mg
Single-dose of 10 mg of TS-142

What researchers measure

Primary outcomes

Plasma concentration
Plasma concentration of unchanged form and its metabolite
Time frame: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Maximum plasma concentration of unchanged form and its metabolite (Cmax)
Time frame: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Time to maximum plasma concentration of unchanged form and its metabolite (tmax)
Time frame: 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)
Time frame: 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)
Time frame: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Terminal elimination rate constant of unchanged form and its metabolite (λz)
Time frame: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Elimination half-life of unchanged form and its metabolite (t1/2)
Time frame: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)
Time frame: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Apparent total body clearance of unchanged form (CL/F)
Time frame: Predose and up to 24 hours postdose

Study locations

1 site

Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05707897
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Feb 1, 2023
Start date: Feb 15, 2023
Primary completion: Mar 20, 2023
Completion: Mar 20, 2023
Last update: Feb 28, 2025

Study contacts

Taisho Director

study director · Taisho Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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