A Food Effect Study of TS-142 in Healthy Subjects

• Sponsor: Taisho Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05707897
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 1.6
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Effect of Food	Drug: TS-142 10 mg	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Assess the Food Effect of TS-142 in Healthy Subjects
• Anticipated Study Start Date: Feb 10, 2023
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

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; Single-dose of 10 mg of TS-142
Experimental: Fasted condition Period in which subjects receive a single oral dose of TS-142 tablet in fasted condition.	Drug: TS-142 10 mg; Single-dose of 10 mg of TS-142

Outcome Measures

Primary Outcome Measures

1. Plasma concentration [Predose and up to 24 hours postdose]

   Plasma concentration of unchanged form and its metabolite

2. Pharmacokinetic parameters [Predose and up to 24 hours postdose]

   Maximum plasma concentration of unchanged form and its metabolite (Cmax)

3. Pharmacokinetic parameters [Predose and up to 24 hours postdose]

   Time to maximum plasma concentration of unchanged form and its metabolite (tmax)

4. Pharmacokinetic parameters [Predose and up to 24 hours postdose]

   Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)

5. Pharmacokinetic parameters [Predose and up to 24 hours postdose]

   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)

6. Pharmacokinetic parameters [Predose and up to 24 hours postdose]

   Terminal elimination rate constant of unchanged form and its metabolite (λz)

7. Pharmacokinetic parameters [Predose and up to 24 hours postdose]

   Elimination half-life of unchanged form and its metabolite (t1/2)

8. Pharmacokinetic parameters [Predose and up to 24 hours postdose]

   Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)

9. Pharmacokinetic parameters [Predose and up to 24 hours postdose]

   Apparent total body clearance of unchanged form (CL/F)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taisho Pharmaceutical Co., Ltd selected site	Tokyo		Japan

Sponsors and Collaborators

• Taisho Pharmaceutical Co., Ltd.

Investigators

• Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taisho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05707897
• Other Study ID Numbers: TS142-304
• First Posted: Feb 1, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 1, 2023