A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
Primary Purpose
Drug Safety, Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MDT-637
Sponsored by
About this trial
This is an interventional treatment trial for Drug Safety focused on measuring RSV
Eligibility Criteria
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
Sites / Locations
- West Coast Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MDT-637
Placebo
Arm Description
Active formulation
Matched Placebo Comparator
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Cmax
Trough MDT-637 Nasal Concentration
Determination of MDT-637 concentration following nasal wash
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Tmax
Plasma pharmacokinetics of MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by AUC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01355016
Brief Title
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MicroDose Therapeutx, Inc
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Safety, Respiratory Syncytial Virus Infections
Keywords
RSV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MDT-637
Arm Type
Experimental
Arm Description
Active formulation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MDT-637
Intervention Description
Inhaled doses of MDT-637 over a 24 hour period
Primary Outcome Measure Information:
Title
Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers
Description
Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.
Time Frame
Up to 22 days (including 14 day screening period)
Secondary Outcome Measure Information:
Title
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Description
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Cmax
Time Frame
Multiple plasma samples collected up to 24 hours post first dose
Title
Trough MDT-637 Nasal Concentration
Description
Determination of MDT-637 concentration following nasal wash
Time Frame
24 hours
Title
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Description
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Tmax
Time Frame
24 hours
Title
Plasma pharmacokinetics of MDT-637 dry powder inhalation
Description
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by AUC
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
West Coast Clinical Trials
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Links:
URL
http://mdtx.com/pipeline/proprietary-products/mdt-637/
Description
Development Program Information
Learn more about this trial
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
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