Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects

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 and elderly participants

Official Title
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A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Step 1: TS-142
* Drug: Step 2: TS-142
* Drug: Step 2: Placebo


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 and body weight is more than 40.0 kg at screening inspection Other protocol defined inclusion criteria could apply Exclusion Criteria: History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant History of drug and food allergy Other protocol defined exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step 1;TS-142<br> | Drug: Step 1: TS-142<br>* Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days<br>|
| Experimental: Step 2;TS-142<br> | Drug: Step 2: TS-142<br>* Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days<br>Drug: Step 2: Placebo<br>* Elderly participants will receive placebo once daily for 7 consective days<br>|
| Placebo Comparator: Step 2;Placebo<br> | Drug: Step 2: TS-142<br>* Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days<br>Drug: Step 2: Placebo<br>* Elderly participants will receive placebo 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 | 
| Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS) | Step2; as a measure of subjective alertness which is scored by 10 cm-VAS scale ranging from 1, extremely alert, to 9, extremely sleepy at the next morning after administration. | Day 1 up to Day 8 |