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Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers

NCT01907776 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-06-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mitsuharu Egawa · Meiji Seika Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01907776 on ClinicalTrials.gov