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

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: TS-172 90 mg; Drug: Placebo; Drug: Moxifloxacin; Drug: TS-172 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06837155

TS172-03-07

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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52 participants in 4 patient groups, including a placebo group

TS-172 20 mg

Experimental group

Treatment:

Drug: TS-172 20 mg

TS-172 90 mg

Experimental group

Treatment:

Drug: TS-172 90 mg

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo