- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01961830
Intrapulmonary Pharmacokinetics of ME1100 in Healthy Volunteers
June 10, 2014 updated by: Meiji Seika Pharma Co., Ltd.
An Open-label, Single Dose Study to Assess Intrapulmonary Pharmacokinetics of ME1100 Inhalation Solution Administered to Healthy Volunteers
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States
- Pulmonary Associates
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male (who are surgically sterile or agree to practice barrier contraception throughout their participation in the study) or Female (using oral, hormonal, or double barrier contraceptive if sexually active, surgically sterile or post-menopausal confirmed by Follicle stimulating hormone(FSH) test)
- Willing to give written informed consent
- 18 to 55 years of age at time of consent Body Mass Index (BMI) of 18-30 kg/m2
- Non-smoker (for at least 6 months prior to screening) and willing to abstain from smoking during the course of the study
- Good general health as determined by medical history, physical examination, Electrocardiogram(ECG) and clinical laboratory tests (including normal renal function and high frequency audiometry)
- Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 72 hours after dosing.
Exclusion Criteria:
- Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator or Medical Monitor would place the subject at risk through study participation or would confound the assessment of the safety of ME1100 inhalation solution
- Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
- History or current symptom(s) of respiratory tract inflammation within 30 days of Visit 2
- History of hearing, balance or ear disorder or surgery or injury to the ears, or with genetic mutation (>5.0% heteroplasmy) suggestive of increased risk of hearing loss (MT-RNR1 [A1555G] for mitochondrial 12S ribosomal RNA gene or MT-TS1 [A3243G] for mitochondrial transfer RNA serine 1)
- History of parent, sibling or parental sibling reporting hearing loss before age 65 years
- History of malignancy
- History of clinically significant alcohol or drug abuse
- History within last 6 months or current use of any tobacco products including e-cigarettes.
- Positive drug screen for drugs of abuse
- Positive test for HIV, Hepatitis B or Hepatitis C
- Use of any prescription or over-the-counter medications (except oral or hormonal contraceptives), herbal supplements, or vitamins within 14 days of Visit 2
- Known hypersensitivity to any aminoglycoside or lidocaine
- Female of childbearing potential with a positive urine pregnancy test, or currently breast feeding.
- Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
- Abnormal Forced Expiratory Volume in the First Second(FEV1), Forced Vital Capacity(FVC), or FEV1/FVC (FEV1 or FVC < 80% of predicted or FEV1/FVC ratio < 0.7)
- FEV1 variability > 10% between V1 and V2 (prior to dosing)
- Significant blood donation (or testing) in previous 8 weeks before screening.
- Use of any Investigational Product in previous 30 days or 5 half-lives, whichever is longer, preceding start of screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ME1100
ME1100 inhalation solution 0.6 mL for 90 mg, Single Dose ME1100 inhalation solution 3.0 mL for 450 mg, Single Dose
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics profile in ELF
Time Frame: 0-12 hours after START of Dosing
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Each subject will undergo fiber-optic bronchoscopy for the collection of bronchoalveolar lavage fluid at one of the following time points:5 minutes after END of dosing, 0.5, 1, 3, 6 and 12 hrs post START of dosing.
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0-12 hours after START of Dosing
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum Concentration of ME1100
Time Frame: 2, 5, 10 minutes after END of dosing, 0.5, 1, 3, 6 and 12 hrs post START of dosing
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2, 5, 10 minutes after END of dosing, 0.5, 1, 3, 6 and 12 hrs post START of dosing
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Number of participants with abnormal safety laboratory measurements
Time Frame: from Baseline to Day 3
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from Baseline to Day 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 8, 2013
First Submitted That Met QC Criteria
October 9, 2013
First Posted (Estimate)
October 11, 2013
Study Record Updates
Last Update Posted (Estimate)
June 12, 2014
Last Update Submitted That Met QC Criteria
June 10, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ME1100-CL-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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