Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.

Key facts

Study ID

NCT00506792

Run by

Novartis Pharmaceuticals

People needed

9

Starts

2007-07-01

Expected to finish

2009-11-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female (women must be post-menopausal or surgically sterile) subjects with cystic fibrosis ages 18 to 50.

You may not qualify if…

• Any presence of seasonal or non-seasonal allergies affecting the nose, nasal passages, throat or sinuses within 2 weeks prior to dosing.
• Any upper respiratory tract infection or signs or symptoms within 2 weeks prior to dosing.
• Any presence of nasal polyps or structural abnormalities, frequent history of nose bleeding, or any recent nasal surgery (within 12 weeks prior to dosing).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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