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

Taisho Pharmaceutical Co., Ltd.23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

Step 1: TS-142DRUG

Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days

Step 2: TS-142DRUG

Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days

Step 2: PlaceboDRUG

Elderly participants will receive placebo once daily for 7 consective days

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sumida Hospital

Sumida-ku, Tokyo, Japan

Outcomes

Primary Outcomes

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

Time frame: Day 1 up to Day 14

Area under the concentration-time curve AUC (tau)

Concentration of TS-142 and its metabolites in plasma

Time frame: 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.

Time frame: Day 1 up to Day 8

Data from ClinicalTrials.gov

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