臨床研究等提出・公開システム

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

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

Takeda Shinichi

National Center of Neurology and Psychiatry

4-1-1,Ogawa-Higashi,kodaira,Tokyo

ke-watanabe@taiho.co.jp

Watanabe Keita

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyodaku, Tokyo

+81-3-3293-2455

ke-watanabe@taiho.co.jp

Complete

May. 12, 2024

Interventional

non-randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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

Male

healthy adult males

Orally administration of TAS-205 (1600mg, 2400mg), placebo and Moxifloxacin

[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

+81-92-283-7701

April. 12, 2024

No

IPD data will not be shared according to the Sponsor policy on data sharing. Taiho clinical trial information disclosure policy may be found at https://www.taiho.co.jp/rd/policies_statements/clinicaltrial_disclosure/

none