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

Taisho Pharmaceutical Co., Ltd.32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

Placebo (fasting)DRUG

Participants will receive placebo once in fasting condition

Placebo (feeding)DRUG

Participants will receive placebo once after meal condition

1 mg of TS-142DRUG

Participants will receive 1 mg of TS-142 once in fasting condition

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 8

Area under the concentration-time curve AUC (tau)

Concentration of TS-142 and its metabolites in plasma

Time frame: 48 hours

Data from ClinicalTrials.gov

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