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

Taisho Pharmaceutical Co., Ltd.24 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 participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

PlaceboDRUG

Participants will receive placebo once daily for 7 consective days

TS-142, 10 mgDRUG

Participants will receive 10 mg of TS-142 once daily for 7 consective days

TS-142, 20 mgDRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The medical facility selected by Taisho Pharmaceutical Co., Ltd

Fukuoka, 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

Data from ClinicalTrials.gov

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