Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers
This study has been completed.
Information provided by:
First received: December 27, 2006
Last updated: June 3, 2010
Last verified: June 2010
This study is designed to assess the effects of two doses of FTY720 on lung (pulmonary) and cardiac (heart) functions in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Parallel Group, Double-blind, Placebo Controlled, 14 Days Multiple-dose Treatment to Assess the Pulmonary and Cardiac Pharmacodynamics of FTY720 (0.5 and 1.25 mg) in Healthy Volunteers|
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Effects of two doses of FTY720 on lung and cardiac (heart) functions in healthy volunteers.
Secondary Outcome Measures:
- Treatment initiation effect on heart rhythm.
- Duration of dynamic effect on heart rate and rhythm.
- Treatment initiation effect and duration of this effect on cardiac output and stroke volume.
- Treatment initiation effect and the duration of this effect on pulmonary function with methacholine challenge.
- Pharmacodynamic effect on absolute lymphocyte count.
|Study Start Date:||October 2006|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
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