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Intrapulmonary Pharmacokinetics of ME1100 in Healthy Volunteers

NCT01961830 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-06-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

ME1100 inhalation solution

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
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 NCT01961830 on ClinicalTrials.gov