A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled MDT-637 Administered to Healthy Volunteers for 10 Days

The purpose of the study is to assess the tolerability and safety of a range of repeated inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States
      • 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:

• Males and/or surgically sterile or post-menopausal females (confirmed by FSH test); males must agree to practice barrier contraception until they are discharged from the study
• Willing to give written informed consent
• 18 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 as determined by medical history, physical examination, spirometry, ECG and clinical laboratory tests
• Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 24 hours after dosing

Exclusion Criteria:

• Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator and Sponsor (MDTx) would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
• Evidence of current or history of respiratory disease; for instance asthma, emphysema, chronic bronchitis or cystic fibrosis.
• Upper respiratory tract infection within 6 weeks of Visit 1
• Symptoms of rhinitis (stuffy nose, rhinorrhea, sneezing, nasal discharge) within 2 weeks of Visit 1
• Current symptoms of cough, dyspnea, wheezing or nocturnal awakenings due to respiratory symptoms
• 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 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
• Inability to perform reproducible spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
• Abnormal QTc interval at Visit 1(>450 msec in males or > 470 msec in females)
• Significant blood donation (or testing) in previous 8 weeks

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDT-637; Active formulation	Drug: MDT-637; Inhaled doses of MDT-637 over a 10 day period
Placebo Comparator: Placebo; Matched Placebo Comparator	Drug: MDT-637; Inhaled doses of MDT-637 over a 10 day period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of 3 escalating doses of MDT-637 dry powder inhalation in healthy volunteers	Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.	Up to 48 days (including up to 28 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 during the dosing period, upto 24 hr post last dose

Collaborators and Investigators

• Sponsor: MicroDose Therapeutx, Inc

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 7, 2011
• First Submitted That Met QC Criteria: December 8, 2011
• First Posted (Estimate): December 9, 2011

Study Record Updates

• Last Update Posted (Estimate): April 12, 2012
• Last Update Submitted That Met QC Criteria: April 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: RSV; Respiratory Syncytial Virus Infection
• Other Study ID Numbers: MDT-637-CP-102