A Thorough QT/QTc Study of TAS5315 in Healthy Adult Subjects

JRCT ID: jRCT2071220108

Registered date:17/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: healthy adult males and females
• Date of first enrollment: 15/03/2023
• Target sample size: 48
• Study type: Interventional
• Intervention(s): Orally administration of TAS5315 (4mg or 8mg), placebo and Moxifloxacin

Outcome(s)

• Primary Outcome: Difference between TAS5315 and placebo in change from baseline in QT-interval corrected by heart rate using Fridericia corrections [QTcF]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

1) Aged 18 or older and younger than 40 years at the time of consent
2) Weigh at least 45.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.0 to < 25.0 kg/m2
3) Vital signs obtained in screening tests within the following ranges
a Systolic blood pressure (in supine position), 90 to 139 mmHg
b Diastolic blood pressure (in supine position), 40 to 89 mmHg
c Body temperature ranging from 35.0 to 37.4
4) Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, and urinalysis) at the time of screening tests

Exclude criteria

1) Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
2) Had a history of torsade de pointes, unconsciousness of uncertain cause and convulsion of uncertain cause
3) Using pacemaker or implantable cardioverter defibrillator, or cardiac resynchronization device
4) Judged by the investigator to be ineligible as a participant of the clinical study based on the 12-lead ECG at the time of screening test (QT-interval corrected by Fridericia corrections [QTcF] is 450 msec or more, etc.)

Related Information

• Primary Sponsor: Nasermoaddeli Ali