NCT01232413

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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 \[ED\]).

Conditions

• Healthy Subjects
• Cardiac Repolarization

Interventions

Type	Name	Description
DRUG	Placebo	Oral
DRUG	ASP1941	Oral
DRUG	Moxifloxacin	Oral

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-11-02
• Last updated: 2011-02-28

Locations

1 site across 1 country: United States