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

Sponsor
MicroDose Therapeutx, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01489306
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
2
Duration (Months)
17.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to assess the tolerability and safety of a range of repeated inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled MDT-637 Administered to Healthy Volunteers for 10 Days
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: MDT-637

Active formulation

Drug: MDT-637
Inhaled doses of MDT-637 over a 10 day period
Placebo Comparator: Placebo

Matched Placebo Comparator

Drug: MDT-637
Inhaled doses of MDT-637 over a 10 day period

Outcome Measures

Primary Outcome Measures

  1. Safety and Tolerability of 3 escalating doses of MDT-637 dry powder inhalation in healthy volunteers [Up to 48 days (including up to 28 days of screening period)]

    Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.

Secondary Outcome Measures

  1. Plasma pharmacokinetics for MDT-637 dry powder inhalation [Multiple plasma samples collected during the dosing period, upto 24 hr post last dose]

    Plasma Samples will be measured to determine MDT-637 pharmacokinetics

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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, spirometry, 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 Sponsor (MDTx) 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; for instance asthma, emphysema, chronic bronchitis or cystic fibrosis.

  • Upper respiratory tract infection within 6 weeks of Visit 1

  • Symptoms of rhinitis (stuffy nose, rhinorrhea, sneezing, nasal discharge) within 2 weeks of Visit 1

  • Current symptoms of cough, dyspnea, wheezing or nocturnal awakenings due to respiratory symptoms

  • 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 urine pregnancy test at Visit 1

  • Inability to perform reproducible spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines

  • 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

Locations

Site City State Country Postal Code
1 West Coast Clinical Trials Cypress California United States

Sponsors and Collaborators

  • MicroDose Therapeutx, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
MicroDose Therapeutx, Inc
ClinicalTrials.gov Identifier:
NCT01489306
Other Study ID Numbers:
  • MDT-637-CP-102
First Posted:
Dec 9, 2011
Last Update Posted:
Apr 12, 2012
Last Verified:
Apr 1, 2012
Keywords provided by MicroDose Therapeutx, Inc
Respiratory Syncytial Virus Infection
RSV

Study Results

No Results Posted as of Apr 12, 2012