healthy adult males and females
Conditions
Interventions
Orally administration of TAS5315 (4mg or 8mg), placebo and Moxifloxacin
Sponsors
Nasermoaddeli Ali
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between TAS5315 and placebo in change from baseline in QT-interval corrected by heart rate using Fridericia corrections [QTcF] | — |
Contacts
Public ContactKotaro Suto
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed