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

NCT ID: NCT04873323

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2021-09-28

Brief Summary

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

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TS-142 10 mg

TS-142 therapeutic dose oral tablet (low dose)

Group Type: EXPERIMENTAL

TS-142

Intervention Type: DRUG

Single dose of TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period

TS-142 30 mg

Description: TS-142 supratherapeutic dose oral tablet (high dose)

Group Type: EXPERIMENTAL

TS-142

Intervention Type: DRUG

Single dose of TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period

Moxifloxacin 400 mg

Moxifloxacin tablet

Group Type: EXPERIMENTAL

Moxifloxacin

Intervention Type: DRUG

Single dose of moxifloxacin 400 mg in the morning under fasting in each period

Placebo

Placebo oral tablet

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Single dose of TS-142 placebo in the morning under fasting in each period

Interventions

TS-142

Single dose of TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period

Intervention Type: DRUG

Moxifloxacin

Single dose of moxifloxacin 400 mg in the morning under fasting in each period

Intervention Type: DRUG

Placebo

Single dose of TS-142 placebo in the morning under fasting in each period

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taisho Direcoter

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

Taisho Pharmaceutical Co., Ltd selected site

Toshima-ku, , Japan

Countries

Japan

Other Identifiers

TS142-209

Identifier Type: -

Identifier Source: org_study_id