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

This study has been completed.
Sponsor:
Information provided by:
MicroDose Therapeutx, Inc
ClinicalTrials.gov Identifier:
NCT01355016
First received: May 11, 2011
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Drug Safety
Respiratory Syncytial Virus Infections
 Drug: MDT-637
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled MDT-637 in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MicroDose Therapeutx, Inc:

Primary Outcome Measures:
  • Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers [ Time Frame: Up to 22 days (including 14 day screening period) ] [ Designated as safety issue: Yes ]
    Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.


Secondary Outcome Measures:
  • Plasma pharmacokinetics for MDT-637 dry powder inhalation [ Time Frame: Multiple plasma samples collected up to 24 hours post first dose ] [ Designated as safety issue: No ]
    Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Cmax

  • Trough MDT-637 Nasal Concentration [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Determination of MDT-637 concentration following nasal wash

  • Plasma pharmacokinetics for MDT-637 dry powder inhalation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Tmax

  • Plasma pharmacokinetics of MDT-637 dry powder inhalation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by AUC


Estimated Enrollment: 48
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDT-637
Active formulation
 Drug: MDT-637
Inhaled doses of MDT-637 over a 24 hour period
Placebo Comparator: Placebo
Matched Placebo Comparator
 Drug: MDT-637
Inhaled doses of MDT-637 over a 24 hour period

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355016

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
MicroDose Therapeutx, Inc
  More Information

Additional Information:
Development Program Information  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT01355016     History of Changes
Other Study ID Numbers: MDT-637-CP-101
Study First Received: May 11, 2011
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MicroDose Therapeutx, Inc:
RSV

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on May 19, 2013