A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis (INCA)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: AZD9668 Placebo equivalent; Drug: AZD9668

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757848

D0520C00009

Details and patient eligibility

About

The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).

Enrollment: 56 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or post-menopausal or surgically sterile female patients
• Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or equal to 40% of normal
• Have normal renal function

Exclusion criteria

• Lung transplant patients
• Significant liver disease
• Any other non-CF-related lung disease that may interfere with study assessments

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

AZD9668

Experimental group

Treatment:

Drug: AZD9668

Placebo

Placebo Comparator group

Treatment:

Drug: AZD9668 Placebo equivalent