A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects

NCT ID: NCT06837155

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-05-26

Brief Summary

A clinical study to evaluate the effects on QT/QTc interval of TS-172 in healthy adults subjects

Conditions

Healthy Volunteers

Study Design

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

Study Groups

TS-172 20 mg

Group Type: EXPERIMENTAL

TS-172 20 mg

Intervention Type: DRUG

oral administration of TS-172 20 mg

TS-172 90 mg

Group Type: EXPERIMENTAL

TS-172 90 mg

Intervention Type: DRUG

oral administration of TS-172 90 mg

Moxifloxacin

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

oral administration of moxifloxacin 400 mg

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral administration of placebo

Interventions

TS-172 20 mg

oral administration of TS-172 20 mg

Intervention Type: DRUG

TS-172 90 mg

oral administration of TS-172 90 mg

Intervention Type: DRUG

Moxifloxacin

oral administration of moxifloxacin 400 mg

Intervention Type: DRUG

Placebo

oral administration of placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Japanese healthy subjects aged =>18 and <40 years at the time of obtaining informed consent

2. Subjects whose body weight is >=40 kg at the screening test, and body mass index is >=18.5 and <25.0

3. Subjects with both heart rates are =>45 and =<100 beats/min on a standard 12-lead electrocardiogram at the screening test and before drug administration in Period 1

Exclusion Criteria

1. Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antibiotics

2. Subjects with a family history or risk factors for aortic aneurysm or aortic dissection (e.g., Marfan syndrome)

3. Subjects with a family history of sudden death

4. Subjects with congenital diseases, heart diseases, or medical history of such conditions

5. Subjects with risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, or a family history of long QT syndrome) or medical history of such conditions

6. Subjects with medical history of syncope suspected to be related to TdP, unexplained syncope, or seizures

7. Subjects with standard 12-lead electrocardiogram waveforms that make it difficult to evaluate QTc prolongation (e.g., drift, EMG interference, T wave morphology, significant sinus arrhythmia, or frequent ectopic beats) at the screening and before the administration of the study drug in Period 1

8. Subjects with a QTcF (QT interval corrected using Fridericia's formula) of =>450 msec in the standard 12-lead ECG test at the screening and before the administration of the study drug in Period 1

• Minimum Eligible Age: 18 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

Locations

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, , Japan

Countries

Japan

Other Identifiers

TS172-03-07

Identifier Type: -

Identifier Source: org_study_id