Clinical Trial: Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study of the Safety and Pharmacokinetics of 552-02 Following 14 Days of Dosing By Inhalation in Patients With Cystic Fibrosis
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.
Detailed Summary:
Sponsor: Parion Sciences
Current Primary Outcome:
- Safety assessments
- Blood and urine laboratory tests
- Pulmonary function tests
- Electrocardiograms
- Vital signs and pulse oximetry
Original Primary Outcome:
- Safety assessments:
- Blood and urine laboratory tests
- Pulmonary function tests
- Electrocardiograms
- Vital signs and pulse oximetry
Current Secondary Outcome: Plasma pharmacokinetics on Day 14 of the study.
Original Secondary Outcome: Same as current
Information By: Parion Sciences
Dates:
Date Received: January 6, 2006
Date Started: January 2006
Date Completion: August 2006
Last Updated: January 12, 2009
Last Verified: January 2009