A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.

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Detailed Description

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Conditions

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Drug Safety Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MDT-637

Active formulation

Group Type EXPERIMENTAL

MDT-637

Intervention Type DRUG

Inhaled doses of MDT-637 over a 24 hour period

Placebo

Matched Placebo Comparator

Group Type PLACEBO_COMPARATOR

MDT-637

Intervention Type DRUG

Inhaled doses of MDT-637 over a 24 hour period

Interventions

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MDT-637

Inhaled doses of MDT-637 over a 24 hour period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and/or surgically sterile or post-menopausal females (confirmed by FSH test); males must agree to practice barrier contraception until they are discharged from the study
* Willing to give written informed consent
* 18 to 50 years of age
* BMI of 19-30 Kg/m2
* Non-smoker (for at least 90 days 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, ECG and clinical laboratory tests
* Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 24 hours after dosing

Exclusion Criteria

* Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator and MDT would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
* Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
* History of significant nasal irritation from nasal inhalation of medication
* History of malignancy
* History of clinically significant alcohol or drug abuse
* Positive drug screen for drugs of abuse
* Positive test for HIV, Hepatitis B or Hepatitis C
* Allergy to lactose, or lactose intolerance
* Use of prescription medication within 14 days of Visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of Visit 2
* Positive serum pregnancy test at Visit 1
* Inability to perform reproducible spirometry
* Abnormal FEV1, FVC, or FEV1/FVC (FEV1and FVC \< 85% of predicted and variability of \<5% or FEV1/FVC ratio \< 0.7)
* Abnormal QTc interval at Visit 1(\>450 msec in males or \> 470 msec in females)
* Significant blood donation (or testing) in previous 8 weeks

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes