A Study of the Effect of ASP1941 on Cardiac Repolarization in Healthy Subjects

Phase 1 Completed 88 enrolled Astellas Pharma Inc

RandomizedCrossoverTriple-blind

Summary

The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on electrocardiogram (ECG) measurements.

Timeline

Start: 2010-09
Primary completion: 2011-02
Completion: 2011-02

Outcome

Met primary endpoint

paper No clinically meaningful QTc interval prolongation was observed in these healthy subjects who received ipragliflozin doses up to 600 mg/d for 7 days. PMID 23910665 ↗

paper The largest upper bounds of the 90% CIs of mean treatment differences from placebo were 4.44 and 3.39 ms for ipragliflozin 600 and 100 mg, respectively PMID 23910665 ↗

Publications

Zhang W, Smulders R, Abeyratne A, Dietz A, Krauwinkel W, Kadokura T, Keirns J. Ipragliflozin does not prolong QTc interval in healthy male and female subjects: a phase I study. Clin Ther. 2013 Aug;35(8):1150-1161.e3. doi: 10.1016/j.clinthera.2013.06.009. Epub 2013 Aug 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Moxifloxacin	Small molecule	400 mg	Oral
Subject	ipragliflozin	Small molecule	100 mg	Oral
Subject	ipragliflozin	Small molecule	600 mg	Oral

Indications

No indication recorded.