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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled MDT-637 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355016
• Other study ID #: MDT-637-CP-101
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2011
• Last updated: April 10, 2012
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: April 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 determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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, 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 MDT 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, including asthma, emphysema, chronic bronchitis, or cystic fibrosis

• 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 serum pregnancy test at Visit 1

• Inability to perform reproducible spirometry

• Abnormal FEV1, FVC, or FEV1/FVC (FEV1and FVC < 85% of predicted and variability of <5% or FEV1/FVC ratio < 0.7)

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Safety
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• MDT-637
Inhaled doses of MDT-637 over a 24 hour period

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	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 6 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 22 days (including 14 day screening period)	Yes
Secondary	Plasma pharmacokinetics for MDT-637 dry powder inhalation	Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Cmax	Multiple plasma samples collected up to 24 hours post first dose	No
Secondary	Trough MDT-637 Nasal Concentration	Determination of MDT-637 concentration following nasal wash	24 hours	No
Secondary	Plasma pharmacokinetics for MDT-637 dry powder inhalation	Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Tmax	24 hours	No
Secondary	Plasma pharmacokinetics of MDT-637 dry powder inhalation	Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by AUC	24 hours	No