Effect of SYR-472 on Cardiac Function in Healthy Adults
- Conditions
- Effects on Cardiac QT/QTc IntervalMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12610000292077
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 260
*Subjects must be healthy volunteers
*Subjects must weigh at least 50 kg and have a body mass index greater than or equal to 18.5 kg/m2 and less than 30 kg/m2
*Subjects must be in good health in the judgment of the investigator.
* Subjects will not be enrolled if the screening electrocardiogram has abnormalities including second- or third-degree atrioventricular block, or one or more of the following: QTcF >450 milliseconds (ms), QRS >120 ms, PR interval of >240 ms or any other rhythm than sinus rhythm, which is interpreted by the investigator to be clinically significant.
* History of additional risk factors for Torsade de pointes (e.g., long QT syndrome)
* Has a heart rate at rest of <50 bpm or >100 bpm
*Uses prescription medications within 4 weeks (28 days) prior to the start of the investigational drug administration
*Use of over-the-counter medications within 1 week (7 days) prior to the start of the investigational drug administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The largest difference in time-matched baseline-adjusted least squares means in QT interval corrected for heart rate using the Fridericia method (QTcF) between SYR-472 and placebo at post-treatment electrocardiogram collection times.[Baseline and Final Collection Date (Up to 23.5 hours post dosing).]
- Secondary Outcome Measures
Name Time Method The difference in time-matched baseline-adjusted least squares means in QTcF and QT interval corrected for heart rate using the study-specific method (QTcss) between SYR-472 and placebo at post-treatment electrocardiogram collection times.[Baseline and Final Collection Date (Up to 23.5 hours post dosing).];Categorical evaluation of the number and percentage of subjects with time-matched increases in QTcF and QTcss intervals of >30 ms and >60 ms from baseline, and the number and percentage of subjects with QTcF and QTcss intervals of >450 ms, >480 ms and >500 ms.[Baseline and Final Collection Date (Up to 23.5 hours post dosing).];Safety assessments including adverse events (potential adverse events are not yet known), safety electrocardiograms, vital signs, weight and clinical laboratory values (hematology and serum chemistry).[Baseline and Final Visit (Up to 8 days post final dosing).]