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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2019-11-30

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

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Step1; No masking

Study Groups

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Step 1;TS-142

Group Type EXPERIMENTAL

Step 1: TS-142

Intervention Type DRUG

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

Step 2;TS-142

Group Type EXPERIMENTAL

Step 2: TS-142

Intervention Type DRUG

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

Step 2: Placebo

Intervention Type DRUG

Elderly participants will receive placebo once daily for 7 consective days

Step 2;Placebo

Group Type PLACEBO_COMPARATOR

Step 2: TS-142

Intervention Type DRUG

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

Step 2: Placebo

Intervention Type DRUG

Elderly participants will receive placebo once daily for 7 consective days

Interventions

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Step 1: TS-142

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

Intervention Type DRUG

Step 2: TS-142

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

Intervention Type DRUG

Step 2: Placebo

Elderly participants will receive placebo once daily for 7 consective days

Intervention Type DRUG

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

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes