A Food Effect Study of TS-142 in Healthy Subjects

Effect of Food Clinical Trial

Official title:

A Study to Assess the Food Effect of TS-142 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05707897
• Other study ID #: TS142-304
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2023
• Est. completion date: March 20, 2023

Study information

• Verified date: January 2023
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Food

Intervention

Drug:
• TS-142 10 mg
Single-dose of 10 mg of TS-142

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration	Plasma concentration of unchanged form and its metabolite	Predose and up to 24 hours postdose
Primary	Pharmacokinetic parameters	Maximum plasma concentration of unchanged form and its metabolite (Cmax)	Predose and up to 24 hours postdose
Primary	Pharmacokinetic parameters	Time to maximum plasma concentration of unchanged form and its metabolite (tmax)	Predose and up to 24 hours postdose
Primary	Pharmacokinetic parameters	Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)	Predose and up to 24 hours postdose
Primary	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)	Predose and up to 24 hours postdose
Primary	Pharmacokinetic parameters	Terminal elimination rate constant of unchanged form and its metabolite (?z)	Predose and up to 24 hours postdose
Primary	Pharmacokinetic parameters	Elimination half-life of unchanged form and its metabolite (t1/2)	Predose and up to 24 hours postdose
Primary	Pharmacokinetic parameters	Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)	Predose and up to 24 hours postdose
Primary	Pharmacokinetic parameters	Apparent total body clearance of unchanged form (CL/F)	Predose and up to 24 hours postdose