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Completed

NCT Number: NCT06837155

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

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

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Key information

Conditions

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Japanese healthy subjects aged =>18 and <40 years at the time of obtaining informed consent
  • Subjects whose body weight is >=40 kg at the screening test, and body mass index is >=18.5 and <25.0
  • 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

  • Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antibiotics
  • Subjects with a family history or risk factors for aortic aneurysm or aortic dissection (e.g., Marfan syndrome)
  • Subjects with a family history of sudden death
  • Subjects with congenital diseases, heart diseases, or medical history of such conditions
  • 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
  • Subjects with medical history of syncope suspected to be related to TdP, unexplained syncope, or seizures
  • 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
  • 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

Treatment and study plan

TS-172 20 mg

Drug

oral administration of TS-172 20 mg

TS-172 90 mg

Drug

oral administration of TS-172 90 mg

moxifloxacin

Drug

oral administration of moxifloxacin 400 mg

Placebo

Drug

oral administration of placebo

Primary outcomes

  1. QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs

    Time frame: Up to 24 hours postdose during each period

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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