Clinical trial NCT01355016: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Safety
Respiratory Syncytial Virus Infections
Keywords: RSV
Lead sponsor: MicroDose Therapeutx, Inc
Sponsor class: INDUSTRY
First posted: 2011-05-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers
timeFrame: Up to 22 days (including 14 day screening period)
Secondary outcomes:
measure: Plasma pharmacokinetics for MDT-637 dry powder inhalation
timeFrame: Multiple plasma samples collected up to 24 hours post first dose
measure: Trough MDT-637 Nasal Concentration
timeFrame: 24 hours
measure: Plasma pharmacokinetics for MDT-637 dry powder inhalation
timeFrame: 24 hours
measure: Plasma pharmacokinetics of MDT-637 dry powder inhalation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials
state: California
Study officials:
References: