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

NCT06837155 | Completed Phase 1

• 1 other identifier: TS172-03-07
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

  Up to 24 hours postdose during each period

Study Arms (4)

TS-172 20 mg

EXPERIMENTAL

Drug: TS-172 20 mg

TS-172 90 mg

EXPERIMENTAL

Drug: TS-172 90 mg

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TS-172 20 mg DRUG

oral administration of TS-172 20 mg

TS-172 20 mg

TS-172 90 mg DRUG

oral administration of TS-172 90 mg

TS-172 90 mg

Moxifloxacin DRUG

oral administration of moxifloxacin 400 mg

Moxifloxacin

Placebo DRUG

oral administration of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: March 3, 2025
• Primary Completion: May 20, 2025
• Study Completion: May 26, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)