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Completed

NCT Number: NCT04169893

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

20 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The medical facility selected by Taisho Pharmaceutical Co., Ltd

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-142

Drug

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

3 mg of TS-142

Drug

Participants will receive 3 mg of TS-142 once in fasting condition

10 mg of TS-142 (fasting)

Drug

Participants will receive 10 mg of TS-142 once in fasting condition

10 mg of TS-142 (feeding)

Drug

Participants will receive 10 mg of TS-142 once after meal condition

30 mg of TS-142

Drug

Participants will receive 30 mg of TS-142 once in fasting condition

Primary outcomes

  1. Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

    Time frame: Day 1 up to Day 8

    Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe

  2. Area under the concentration-time curve AUC (tau)

    Time frame: 48 hours

    Concentration of TS-142 and its metabolites in plasma

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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