A QT/QTc Evaluation Study of TS-142 in Healthy Adult Subjects

A Study to Evaluate the Effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects

A clinical study to evaluate the effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: TS-142; Drug: Moxifloxacin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Toshima-ku, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Japanese Males or females aged 20 years or older but less than 40 years at the time of informed consent
• those with a BMI of 18.5 in male (17.6 in female) or more and less than 25.0 and a body weight of 40.0 kg or more at screening test
• those whose pulse rate measured by standard 12-lead ECG is 50 beats/min or more but no more than 90 beats/min at screening test and at the time before administration of investigational drug in period 1
• those who are judged eligible to participate in the study by the principal investigator or sub-investigator based on the results of screening test and test conducted before administration of investigational drug in period 1. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator or subinvestigator.
• those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.

Exclusion Criteria:

• Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
• Subjects with a medical history considered inappropriate for participation in the study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrine, metabolic, hematological, immune, skin, neurological, and psychiatric diseases.
• Subjects with a history of drug allergy or food allergy.
• Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antimicrobials
• Subjects with risk factors or with a history of risk factors for aortic aneurysm, aortic dissection (such as Marfan syndrome)
• Subjects with significant allergic predisposition (such as asthma requiring medical treatment)
• Subjects with congenital disease, heart disease, or a history of heart disease
• Subjects with risk factors or with a history of risk factors for torsade de pointes (TdP) (heart failure, hypokalemia, family history of long QT syndrome, etc.)
• Subjects with a history of unconscious seizures suspected of involving TdP.
• Subjects with waveforms difficult to assess for QTc interval prolongation in standard 12-lead ECG at screening and the timing before administration of investigational product in period 1 (drift, electromyography contamination, T-wave geometry, marked sinus arrhythmia, frequent premature beats, etc.)
• Subjects with QTcF(Fridericia correction method) of at least 450 msec in men and at least 470 msec in women in standard-12-lead ECG at screening test and at the time before administration of investigational product in period 1.
• Subjects with suicidal ideation, suicide attempt on the Colombian Suicide Assessment Scale (C-SSRS) on Day-1 or a history of suicide attempt within the previous 5 years.
• Other protocol defined inclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TS-142 10 mg; TS-142 therapeutic dose oral tablet (low dose)	Drug: TS-142; Single dose of TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period
Experimental: TS-142 30 mg; Description: TS-142 supratherapeutic dose oral tablet (high dose)	Drug: TS-142; Single dose of TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period
Experimental: Moxifloxacin 400 mg; Moxifloxacin tablet	Drug: Moxifloxacin; Single dose of moxifloxacin 400 mg in the morning under fasting in each period
Experimental: Placebo; Placebo oral tablet	Drug: Placebo; Single dose of TS-142 placebo in the morning under fasting in each period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs	Difference (ΔΔQTc) in change from baseline (ΔQTc) in QTc interval at each time point in each group compared with the placebo group	Up to 24 hours postdose during each period

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Direcoter, Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): September 28, 2021

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Moxifloxacin
• Other Study ID Numbers: TS142-209

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
• product manufactured in and exported from the U.S.: No