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

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

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.

Study Overview

• Status: Completed
• Conditions: Drug Safety
• Intervention / Treatment: Drug: Placebo; Drug: MDT-637

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92626
      • West Coast Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Active Comparator: Experimental: MDT-637	Drug: MDT-637; Inhaled doses of MDT-637 over a 24 hour period at 3 visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MicroDose Therapeutx, Inc
• Investigators: Principal Investigator: Purvee Shah, MD, West Coast Clinical Trials

Publications and helpful links

Helpful Links

• Development Program Information

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 15, 2012
• First Posted (Estimate): March 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 22, 2012
• Last Update Submitted That Met QC Criteria: May 21, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: RSV; Respiratory Syncytial Virus Infection
• Other Study ID Numbers: MDT-637-CP-103