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

October 24, 2023 updated by: Taisho Pharmaceutical Co., Ltd.

A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Repeated Doses) (A Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)

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 Overview

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Fukuoka, Japan
        • The medical facility selected by Taisho Pharmaceutical Co., Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo once daily for 7 consective days
Participants will receive 10 mg of TS-142 once daily for 7 consective days
Participants will receive 20 mg of TS-142 once daily for 7 consective days
Participants will receive 30 mg of TS-142 once daily for 7 consective days
Experimental: TS-142 10 mg
Participants will receive placebo once daily for 7 consective days
Participants will receive 10 mg of TS-142 once daily for 7 consective days
Participants will receive 20 mg of TS-142 once daily for 7 consective days
Participants will receive 30 mg of TS-142 once daily for 7 consective days
Experimental: TS-142 20 mg
Participants will receive placebo once daily for 7 consective days
Participants will receive 10 mg of TS-142 once daily for 7 consective days
Participants will receive 20 mg of TS-142 once daily for 7 consective days
Participants will receive 30 mg of TS-142 once daily for 7 consective days
Experimental: TS-142 30 mg
Participants will receive placebo once daily for 7 consective days
Participants will receive 10 mg of TS-142 once daily for 7 consective days
Participants will receive 20 mg of TS-142 once daily for 7 consective days
Participants will receive 30 mg of TS-142 once daily for 7 consective days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 up to Day 14
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
Day 1 up to Day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Shigeru Okuyama, Taisho Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2016

Primary Completion (Actual)

October 8, 2016

Study Completion (Actual)

October 8, 2016

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • TS142-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteer

Clinical Trials on Placebo

3
Subscribe