A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01556607
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : May 22, 2012
Information provided by (Responsible Party):
MicroDose Therapeutx, Inc

Brief Summary:
The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.

Condition or disease Intervention/treatment Phase
Drug Safety Drug: MDT-637 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, 3 Period Crossover, Single Ascending Dose Study to Assess the Safety, and Tolerability of Inhaled MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma
Study Start Date : March 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Experimental: MDT-637 Drug: MDT-637
Inhaled doses of MDT-637 over a 24 hour period at 3 visits

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma. [ Time Frame: Up to 61 days (including up to 42 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 [ Time Frame: Multiple plasma samples collected, upto 24 hr post last dose ]
    Plasma Samples will be measured to determine MDT-637 pharmacokinetics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Documented clinical history and physician diagnosis of intermittent or mild or moderate persistent asthma for at least 6 months prior to screening OR subjects with historical record of Beta-agonist reversibility within previous 5 years
  2. Subjects must demonstrate bronchial hyper-reactivity on methacholine challenge of PC20 less than 8mg/mL.
  3. Visit 2 FEV1 (with no treatment change in the interim) must be within 12% of Visit 1 result
  4. Males and/or females (if not surgically sterile or confirmed to be post menopausal) must agree to practice 2 barrier contraception methods until they are discharged from the study
  5. Willing to give written informed consent
  6. 18 to 50 years of age
  7. BMI of 19-30 kg/m2
  8. Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study
  9. Good general health (excepting asthma) as determined by medical history, physical examination, ECG and clinical laboratory tests
  10. Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to dosing and for 24 hours after dosing.

Exclusion Criteria:

  1. Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator, Medical Monitor or Sponsor (MicroDose Therapeutx; MDTx) would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
  2. Inability to perform acceptable and repeatable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
  3. Abnormal FEV1, FVC, or FEV1/FVC (FEV1 and FVC < 75% of predicted and/or FEV1/FVC ratio < 0.7)
  4. FEV1 variability > 12% between Visit 1 and Visit 2
  5. Evidence of current or history of additional respiratory disease (other than asthma); for instance emphysema, chronic bronchitis or cystic fibrosis.
  6. Upper respiratory tract infection within 6 weeks of Visit 1
  7. Use of rescue albuterol or other short acting bronchodilator (SAB) more often than five times per week
  8. History of significant nasal irritation from nasal inhalation of medication
  9. History of malignancy
  10. History of clinically significant alcohol or drug abuse
  11. Positive drug screen for drugs of abuse
  12. Positive test for HIV, Hepatitis B or Hepatitis C
  13. Allergy to lactose, or lactose intolerance
  14. Use of prescription medication (other than SAB and/or low dose inhaled corticosteroid e.g. fluticasone propionate 44 mcg BID or budesonide 100 mcg BID or equivalent) within 14 days of Visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of Visit 2
  15. Positive urine pregnancy test at Visit 1 or Visit 2 or visit 4
  16. Abnormal QTc interval at Visit 1(> 450 msec in males or > 470 msec in females)
  17. Significant blood donation (or testing) in previous 8 weeks
  18. Use of any Investigational Product in previous 6 weeks (small molecule products) or previous 3 months (biologic products)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01556607

United States, California
West Coast Clinical Trials
Costa Mesa, California, United States, 92626
Sponsors and Collaborators
MicroDose Therapeutx, Inc
Principal Investigator: Purvee Shah, MD West Coast Clinical Trials

Responsible Party: MicroDose Therapeutx, Inc Identifier: NCT01556607     History of Changes
Other Study ID Numbers: MDT-637-CP-103
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012

Keywords provided by MicroDose Therapeutx, Inc:
Respiratory Syncytial Virus Infection