- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04169906
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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.
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