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

NCT ID: NCT01556607

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-05-31

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.

Conditions

Drug Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: MDT-637

Group Type: ACTIVE_COMPARATOR

MDT-637

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

MDT-637

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

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroDose Therapeutx, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Purvee Shah, MD

Role: PRINCIPAL_INVESTIGATOR

West Coast Clinical Trials

Locations

West Coast Clinical Trials

Costa Mesa, California, United States

Countries

United States

Related Links

http://mdtx.com/pipeline/proprietary-products/mdt-637/

Development Program Information

Other Identifiers

MDT-637-CP-103

Identifier Type: -

Identifier Source: org_study_id