NCT00777595

Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers

A Randomized, Double Blind, Single Dose, Positive and Placebo Controlled, Crossover Study of the Effects of Inhaled Carmoterol, at the Proposed Therapeutic and Supratherapeutic Doses, on the QTc Intervals in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of single doses of therapeutic and supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy subjects compared with placebo.

Detailed description

The secondary purposes of this study are to 1) determine if there is a relationship between the duration of the QTc intervals and the plasma concentrations of carmoterol; 2) expand the available information on plasma pharmacokinetics and urine excretion for inhaled carmoterol at the proposed therapeutic and supra-therapeutic doses; and 3) generate additional safety information.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	CHF 4226 pMDI	Inhaled solution, single therapeutic dose
DRUG	CHF 4226 pMDI	Inhaled solution, single supratherapeutic dose
DRUG	Placebo	Inhaled solution, single dose of placebo
DRUG	Moxifloxacin	Tablet, oral, 400mg, single dose

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-10-22
• Last updated: 2009-03-27

Locations

1 site across 1 country: United States