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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01556607
Other study ID # MDT-637-CP-103
Secondary ID
Status Completed
Phase Phase 1
First received March 14, 2012
Last updated May 21, 2012
Start date March 2012
Est. completion date May 2012

Study information

Verified date May 2012
Source MicroDose Therapeutx, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MDT-637
Inhaled doses of MDT-637 over a 24 hour period at 3 visits
Placebo


Locations

Country Name City State
United States West Coast Clinical Trials Costa Mesa California

Sponsors (1)

Lead Sponsor Collaborator
MicroDose Therapeutx, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma. Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events. Up to 61 days (including up to 42 days of screening period) Yes
Secondary Plasma pharmacokinetics for MDT-637 dry powder inhalation Plasma Samples will be measured to determine MDT-637 pharmacokinetics Multiple plasma samples collected, upto 24 hr post last dose No
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