healthy adult males
Conditions
Interventions
Orally administration of TAS-205 (1600mg, 2400mg), placebo and Moxifloxacin
Sponsors
Takeda Shinichi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [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 | — |
Contacts
Public ContactKeita Watanabe
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed