A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly participants.

Official Title
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A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Repeated Doses) (A Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Placebo
* Drug: TS-142, 10 mg
* Drug: TS-142, 20 mg
* Drug: TS-142, 30 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection Exclusion Criteria: History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study History of drug and food allergy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Participants will receive placebo once daily for 7 consective days<br>Drug: TS-142, 10 mg<br>* Participants will receive 10 mg of TS-142 once daily for 7 consective days<br>Drug: TS-142, 20 mg<br>* Participants will receive 20 mg of TS-142 once daily for 7 consective days<br>Drug: TS-142, 30 mg<br>* Participants will receive 30 mg of TS-142 once daily for 7 consective days<br>|
| Experimental: TS-142 10 mg<br> | Drug: Placebo<br>* Participants will receive placebo once daily for 7 consective days<br>Drug: TS-142, 10 mg<br>* Participants will receive 10 mg of TS-142 once daily for 7 consective days<br>Drug: TS-142, 20 mg<br>* Participants will receive 20 mg of TS-142 once daily for 7 consective days<br>Drug: TS-142, 30 mg<br>* Participants will receive 30 mg of TS-142 once daily for 7 consective days<br>|
| Experimental: TS-142 20 mg<br> | Drug: Placebo<br>* Participants will receive placebo once daily for 7 consective days<br>Drug: TS-142, 10 mg<br>* Participants will receive 10 mg of TS-142 once daily for 7 consective days<br>Drug: TS-142, 20 mg<br>* Participants will receive 20 mg of TS-142 once daily for 7 consective days<br>Drug: TS-142, 30 mg<br>* Participants will receive 30 mg of TS-142 once daily for 7 consective days<br>|
| Experimental: TS-142 30 mg<br> | Drug: Placebo<br>* Participants will receive placebo once daily for 7 consective days<br>Drug: TS-142, 10 mg<br>* Participants will receive 10 mg of TS-142 once daily for 7 consective days<br>Drug: TS-142, 20 mg<br>* Participants will receive 20 mg of TS-142 once daily for 7 consective days<br>Drug: TS-142, 30 mg<br>* Participants will receive 30 mg of TS-142 once daily for 7 consective days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe | Day 1 up to Day 14 | 
| Area under the concentration-time curve AUC (tau) | Concentration of TS-142 and its metabolites in plasma | Day 1 up to Day 9 |