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

Sponsor

MicroDose Therapeutx, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01355016

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Drug Safety Respiratory Syncytial Virus Infections	Drug: MDT-637	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MDT-637 Active formulation	Drug: MDT-637 Inhaled doses of MDT-637 over a 24 hour period
Placebo Comparator: Placebo Matched Placebo Comparator	Drug: MDT-637 Inhaled doses of MDT-637 over a 24 hour period

Arm

Intervention/Treatment

Experimental: MDT-637

Active formulation

Drug: MDT-637

Inhaled doses of MDT-637 over a 24 hour period

Placebo Comparator: Placebo

Matched Placebo Comparator

Drug: MDT-637

Inhaled doses of MDT-637 over a 24 hour period

Outcome Measures

Primary Outcome Measures

Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers [Up to 22 days (including 14 day screening period)]
Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.

Secondary Outcome Measures

Plasma pharmacokinetics for MDT-637 dry powder inhalation [Multiple plasma samples collected up to 24 hours post first dose]
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Cmax
Trough MDT-637 Nasal Concentration [24 hours]
Determination of MDT-637 concentration following nasal wash
Plasma pharmacokinetics for MDT-637 dry powder inhalation [24 hours]
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Tmax
Plasma pharmacokinetics of MDT-637 dry powder inhalation [24 hours]
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by AUC

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Clinical Trials	Cypress	California	United States	90630

Sponsors and Collaborators

MicroDose Therapeutx, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Development Program Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01355016

Other Study ID Numbers:

MDT-637-CP-101

First Posted:

May 17, 2011

Last Update Posted:

Apr 12, 2012

Last Verified:

Apr 1, 2012

Keywords provided by , ,

RSV

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Apr 12, 2012