Evaluating the effects of TS-172 on heart rhythm in healthy adults

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

This study is testing how a new drug called TS-172 affects heart rhythm in healthy adults compared to a placebo and a standard heart medication.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 39 Years
• Sex: All
• Sponsor: Taisho Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Tokyo)
• Trial ID: NCT06837155 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the impact of the drug TS-172 on the QT/QTc interval in healthy adult volunteers. Participants will receive different doses of TS-172, as well as a placebo and a standard drug, moxifloxacin, for comparison. The study will involve monitoring heart rates and conducting electrocardiograms to ensure safety and efficacy. The focus is on understanding how TS-172 affects heart rhythm in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates are Japanese healthy adults aged 18 to 40 with a normal body mass index and heart rate.

Not a fit: Patients with a history of heart conditions or those at risk for heart rhythm abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the cardiac safety profile of TS-172, potentially leading to safer drug development.

How similar studies have performed: While this specific approach is focused on a new drug, similar studies evaluating QT/QTc intervals have been conducted successfully in the past.

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

Where this trial is running

Tokyo

• Taisho Pharmaceutical Co., Ltd selected site — Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: Taisho Pharmaceutical Co., Ltd.

Conditions: Healthy Volunteers