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Completed

NCT Number: NCT04087707

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

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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Key information

Conditions

Healthy Volunteer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sumida Hospital

Sumida-ku, Tokyo, 130-0004, 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 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

Treatment and study plan

Step 1: TS-142

Drug

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

Step 2: TS-142

Drug

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

Step 2: Placebo

Drug

Elderly participants will receive placebo once daily for 7 consective days

Primary outcomes

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

    Time frame: Day 1 up to Day 14

    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: Day 1 up to Day 9

    Concentration of TS-142 and its metabolites in plasma

  3. Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)

    Time frame: Day 1 up to Day 8

    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.

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 12, 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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