Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Amikacin

Criteria

Key Inclusion Criteria:

• Male or female study subjects must be adults (≥ 6 years of age)

• Confirmed diagnosis of CF

• History of chronic infection with P.aeruginosa

• FEV1 ≥40% of predicted at Screening

• Ability to comply with study medication use, study visits and procedures

• Ability to produce 0.5 grams of sputum

Key Exclusion Criteria:

• Administration of any investigational drug within 8 weeks to Study Day 1

• Emergency room visit or hospitalization for CF or respiratory-related illness within 4 weeks prior to screening

• History of alcohol, medication or illicit drug abuse within 1 yr. to screening

• History of lung transplantation

• Female of childbearing potential who are not practicing an acceptable method of birth control or who are lactating

• Positive Pregnancy test

• Use of any anti-pseudomonal antibiotics within 28 days prior to Study Day 1

• Initiation of chronic therapy within 28 days prior to Study Day 1

• History of sputum or throat swab culture yielding Burkholderia cepacia within 2 years prior to screening

• History of mycobacterial and/or Aspergillus infection requiring treatment within 2 years prior to screening

• History of biliary cirrhosis with portal hypertension, or splenomegaly