The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on electrocardiogram (ECG) measurements.
Subjects will be randomized in four treatment sequences of twenty subjects each. Subjects in each treatment sequence will participate in a total of four treatment periods (A, B, C, and D) separated by washout periods of at least 7 days from completion of the prior period (Day 8) through clinical check-in (Day -1) of the next study period. For Period 1, subjects will be admitted to the clinical research unit on Day -2. For each subsequent study period, subjects will be admitted to the clinical research unit on Day -1. Subjects will be discharged from the unit after completing procedures on Day 8 of each period. Subjects will receive a follow-up telephone call 7-10 days after their last clinic day (Period 4\\Early Discontinuation \[ED\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
88
Unnamed facility
West Bend, Wisconsin, United States
QTcF evaluated through electrocardiogram analysis (ECG)
QTcF is a QT interval corrected for heart rate (Fridericia's formula)
Time frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)
Evaluation of Electrocardiogram (ECG)
Time frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)
QTcI evaluated through electrocardiogram analysis
QTcI is a QT interval corrected for individual heart rate
Time frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)
QTcB evaluated through electrocardiogram analysis (ECG)
QTcB is a QT interval corrected for heart rate (Bazett's formula)
Time frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)
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