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

Novartis

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: QAU145; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00506792

CQAU145A2201

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

QAU145

Treatment:

Drug: QAU145

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo