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Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics

Healthy Clinical Trial

Official title:
Phase I, Reference-controlled, Dose Escalating Study to Examine the Pharmacokinetics and Safety of AeroVanc Inhalation Powder.

Clinical Trial Summary

The study is carried out to evaluate the safety, tolerability and pharmacokinetics of AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.

Clinical Trial Description

The study has three main objectives:

- To evaluate the safety, and tolerability of AeroVanc inhalation powder in healthy volunteers, and in patients with CF.

- To determine the systemic bioavailability of vancomycin in healthy volunteers following single dose pulmonary administration of 16 mg, 32 mg, and 80 mg doses of AeroVanc in comparison with a 250 mg dose of vancomycin administered intravenously.

- To estimate the lung sputum concentrations of vancomycin in patients with cystic fibrosis (CF) following single dose pulmonary administration of 32 mg and 80 mg doses of AeroVanc. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01537666
Study type Interventional
Source Savara Inc.
Contact
Status Completed
Phase Phase 1
Start date November 2011
Completion date March 2012
View Details
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