drugset / Trial / NCT01961830

Intrapulmonary Pharmacokinetics of ME1100 in Healthy Volunteers

NCT01961830 ↗

Phase 1 Completed 42 enrolled Meiji Seika Pharma Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a single-center, open-label, single-dose study. The primary objective is to determine Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose. The secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess tolerability and safety of a single dose of ME1100 inhalation solution.

Timeline

Start
2013-09
Primary completion
2013-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Arbekacin Unknown 90 mg Inhaled
Subject Arbekacin Unknown 450 mg Inhaled

Indications

No indication recorded.