Healthy Subjects Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Repeat Oral Doses of ASP1941 on Cardiac Repolarization in Healthy Male and Female Adult Subjects
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]).
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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