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

NCT01556607 | Completed Phase 1

• 1 other identifier: MDT-637-CP-103
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Respiratory Syncytial Virus Infection; RSV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Plasma pharmacokinetics for MDT-637 dry powder inhalation

  Multiple plasma samples collected, upto 24 hr post last dose

Study Arms (2)

Experimental: MDT-637

ACTIVE COMPARATOR

Drug: MDT-637

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MDT-637 DRUG

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

Experimental: MDT-637

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Subjects must demonstrate bronchial hyper-reactivity on methacholine challenge of PC20 less than 8mg/mL.
• Visit 2 FEV1 (with no treatment change in the interim) must be within 12% of Visit 1 result
• 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
• Willing to give written informed consent
• to 50 years of age
• BMI of 19-30 kg/m2
• Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study
• Good general health (excepting asthma) as determined by medical history, physical examination, ECG and clinical laboratory tests
• Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to dosing and for 24 hours after dosing.

You may not qualify if:

• 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
• Inability to perform acceptable and repeatable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
• Abnormal FEV1, FVC, or FEV1/FVC (FEV1 and FVC \< 75% of predicted and/or FEV1/FVC ratio \< 0.7)
• FEV1 variability \> 12% between Visit 1 and Visit 2
• Evidence of current or history of additional respiratory disease (other than asthma); for instance emphysema, chronic bronchitis or cystic fibrosis.
• Upper respiratory tract infection within 6 weeks of Visit 1
• Use of rescue albuterol or other short acting bronchodilator (SAB) more often than five times per week
• History of significant nasal irritation from nasal inhalation of medication
• History of malignancy
• History of clinically significant alcohol or drug abuse
• Positive drug screen for drugs of abuse
• Positive test for HIV, Hepatitis B or Hepatitis C
• Allergy to lactose, or lactose intolerance
• 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
• Positive urine pregnancy test at Visit 1 or Visit 2 or visit 4

Sponsors & Collaborators

• MicroDose Therapeutx, Inc: lead

Study Sites (1)

West Coast Clinical Trials

Costa Mesa, California, 92626, United States

Location

Related Links

• Development Program Information

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

VP-14637

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Purvee Shah, MD

  West Coast Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 22, 2012

Record last verified: 2012-05

Locations

US (1)