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

Drug Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556607
• Other study ID #: MDT-637-CP-103
• 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

• Drug Safety

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