A Thorough QT/QTc Study of TAS-205 in Healthy Male Adult Subjects

JRCT ID: jRCT2071230127

Registered date:11/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: healthy adult males
• Date of first enrollment: 12/05/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Orally administration of TAS-205 (1200mg, 2400mg, 3600mg), placebo and Moxifloxacin

Outcome(s)

Primary Outcome

[Safety Confirmation Cohort]
-Adverse Events Exposed to Investigational New Drugs (TEAEs)
-Adverse events related to the investigational drug (TRAE)

[Cardiac safety evaluation cohort]
Difference from placebo in change from baseline in QT interval (QTcF) corrected for heart rate using the Fridericia correction method

Key inclusion & exclusion criteria

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

Include criteria

1. Healthy Japanese male who has given written consent to participate in this study
2. 18 to 40 years of age at the time of consent
3. weigh 50 kg or more but less than 90 kg at screening and have a body mass index (BMI) {body mass [kg]/(height [m])2} of 18.0 or more
Body mass index (BMI) {body weight [kg]/(height [m])2} is between 18.0 and 25.0
4. Vital signs at the time of screening are as follows
Systolic blood pressure (supine): 90 mmHg to less than 140 mmHg
Diastolic blood pressure (supine): 40 mmHg to less than 90 mmHg
Pulse rate: 40 beats/minute to less than 100 beats/minute
Body temperature: 35.0 degrees Celsius to less than 37.4 degrees Celsius
5. Oral administration of the investigational drug is allowed.
6. Willing and able to comply with the visit schedule and study procedures specified in this study.

Exclude criteria

1. A QTcF interval of 450 msec or more based on a resting 12-lead ECG at screening.
2. Clinically significant abnormality on resting 12-lead ECG at screening.
3. Risk factors for Torsades de pointes (heart failure, hypokalemia, or QT prolongation syndrome, etc.)
4. History of ventricular arrhythmias (except occasional ventricular extrasystoles)
5. Use of a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization device

Related Information

• Primary Sponsor: Takeda Shinichi