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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06837155

Enrollment

Registered

2025-02-20

Start date

2025-03-03

Completion date

2025-05-26

Last updated

2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DRUGTS-172 20 mg

oral administration of TS-172 20 mg

DRUGTS-172 90 mg

oral administration of TS-172 90 mg

DRUGMoxifloxacin

oral administration of moxifloxacin 400 mg

DRUGPlacebo

oral administration of placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs	Up to 24 hours postdose during each period

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026