NCT01537666

Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Savara Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy
• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	AeroVanc	Vancomycin hydrochloride dry powder for inhalation
DRUG	IV vancomycin hydrochloride	Vancomycin hydrochloride solution for intravenous administration

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-02-23
• Last updated: 2014-03-31
• Results posted: 2014-03-04

Locations

2 sites across 1 country: Australia