Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
- Registration Number
- NCT00506792
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Male and female (women must be post-menopausal or surgically sterile) subjects with cystic fibrosis ages 18 to 50.
Exclusion Criteria
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 QAU145 QAU145 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Pharmacodynamic response to single intranasal doses of QAU145 in cystic fibrosis patients using nasal potential difference measurements up to 6 hours post-dose. Part I: Baseline, 2 hr post dose, after each dose, end of Part I. Part II: Pre dose and 2 hours post each dose
- Secondary Outcome Measures
Name Time Method Safety and tolerability of single ascending doses assessed by nasal examinations, adverse events, medications, and a nasal symptom questionnaire. Pharmacokinetics up to 6 hours post-dose Part I: Throughout study (about 8 weeks) Part II: Throughout study (about 9 weeks)
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States