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

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.

Official Title
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A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single 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 (fasting)
* Drug: Placebo (feeding)
* Drug: 1 mg of TS-142
* Drug: 3 mg of TS-142
* Drug: 10 mg of TS-142 (fasting)
* Drug: 10 mg of TS-142 (feeding)
* Drug: 30 mg of TS-142


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: Arm Title: Placebo (fasting)<br>fasting | Drug: Placebo (fasting)<br>* Participants will receive placebo once in fasting condition<br>Drug: 1 mg of TS-142<br>* Participants will receive 1 mg of TS-142 once in fasting condition<br>Drug: 3 mg of TS-142<br>* Participants will receive 3 mg of TS-142 once in fasting condition<br>Drug: 10 mg of TS-142 (fasting)<br>* Participants will receive 10 mg of TS-142 once in fasting condition<br>Drug: 30 mg of TS-142<br>* Participants will receive 30 mg of TS-142 once in fasting condition<br>|
| Placebo Comparator: Placebo (feeding)<br>after meal | Drug: Placebo (feeding)<br>* Participants will receive placebo once after meal condition<br>Drug: 10 mg of TS-142 (feeding)<br>* Participants will receive 10 mg of TS-142 once after meal condition<br>|
| Experimental: TS-142, 1 mg<br>fasting | Drug: Placebo (fasting)<br>* Participants will receive placebo once in fasting condition<br>Drug: 3 mg of TS-142<br>* Participants will receive 3 mg of TS-142 once in fasting condition<br>Drug: 10 mg of TS-142 (fasting)<br>* Participants will receive 10 mg of TS-142 once in fasting condition<br>Drug: 30 mg of TS-142<br>* Participants will receive 30 mg of TS-142 once in fasting condition<br>|
| Experimental: TS-142, 3 mg<br>fasting | Drug: 1 mg of TS-142<br>* Participants will receive 1 mg of TS-142 once in fasting condition<br>Drug: 3 mg of TS-142<br>* Participants will receive 3 mg of TS-142 once in fasting condition<br>Drug: 10 mg of TS-142 (fasting)<br>* Participants will receive 10 mg of TS-142 once in fasting condition<br>Drug: 30 mg of TS-142<br>* Participants will receive 30 mg of TS-142 once in fasting condition<br>|
| Experimental: TS-142, 10 mg (fasting)<br>fasting | Drug: Placebo (fasting)<br>* Participants will receive placebo once in fasting condition<br>Drug: 1 mg of TS-142<br>* Participants will receive 1 mg of TS-142 once in fasting condition<br>Drug: 3 mg of TS-142<br>* Participants will receive 3 mg of TS-142 once in fasting condition<br>Drug: 10 mg of TS-142 (fasting)<br>* Participants will receive 10 mg of TS-142 once in fasting condition<br>Drug: 10 mg of TS-142 (feeding)<br>* Participants will receive 10 mg of TS-142 once after meal condition<br>Drug: 30 mg of TS-142<br>* Participants will receive 30 mg of TS-142 once in fasting condition<br>|
| Experimental: TS-142, 10 mg (feeding)<br>after meal | Drug: Placebo (feeding)<br>* Participants will receive placebo once after meal condition<br>Drug: 10 mg of TS-142 (fasting)<br>* Participants will receive 10 mg of TS-142 once in fasting condition<br>Drug: 10 mg of TS-142 (feeding)<br>* Participants will receive 10 mg of TS-142 once after meal condition<br>|
| Experimental: TS-142, 30 mg<br>fasting | Drug: Placebo (fasting)<br>* Participants will receive placebo once in fasting condition<br>Drug: 1 mg of TS-142<br>* Participants will receive 1 mg of TS-142 once in fasting condition<br>Drug: 3 mg of TS-142<br>* Participants will receive 3 mg of TS-142 once in fasting condition<br>Drug: 10 mg of TS-142 (fasting)<br>* Participants will receive 10 mg of TS-142 once in fasting condition<br>Drug: 30 mg of TS-142<br>* Participants will receive 30 mg of TS-142 once in fasting condition<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 8 | 
| Area under the concentration-time curve AUC (tau) | Concentration of TS-142 and its metabolites in plasma | 48 hours |