NCT01907776

Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ME1100 Inhalation Solution (Arbekacin Inhalation Solution) Administered to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Meiji Seika Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic exposure to, and urinary elimination of, ME1100.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ME1100 inhalation solution	ME1100 inhalation solution (arbekacin for oral inhalation at 150mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose
DRUG	ME1100 placebo inhalation solution	Vehicle placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-12-01
• First posted: 2013-07-25
• Last updated: 2014-06-12

Locations

1 site across 1 country: United States