QTc Study of Rosi XR in Healthy Volunteers — Rosi XR  

Alzheimer's Disease Clinical Trial

Official title: A Study to Evaluate the Effect of Extended Release Rosiglitazone (RSG XR) on Cardiac Conduction as Compared to Placebo and a Single Oral Dose of Moxifloxacin

Status Withdrawn

Clinical Trial Summary

This study is a randomised double blind, parallel group, and will evaluate the effects of repeat oral doses of RSG- XR for 21 days on the QTc interval compared to placebo in a population of healthy adult males and females.

Clinical Trial Description

An extended release (XR) formulation of rosiglitazone maleate (RSG), a new formulation of rosiglitazone, is being investigated as a treatment for patients with mild to moderate Alzheimer's disease (AD).

This study is a randomised double blind, parallel group, and will evaluate the effects of repeat oral doses of RSG- XR for 21 days (due to the long half-life of the main metabolite M10) on the QTc interval compared to placebo in a population of healthy adult males and females between 18 and 45 years of age. Moxifloxacin, a drug with well-quantified QTc prolongation, will be included as a positive control in order to validate the ability of the study to detect small changes in QTc. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT00884533
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2009
• Completion date: August 2009