NCT01489306

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

December 7, 2011

Last Update Submit

April 10, 2012

Conditions

Drug Safety

Keywords

Respiratory Syncytial Virus InfectionRSV

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Plasma pharmacokinetics for MDT-637 dry powder inhalation

    Multiple plasma samples collected during the dosing period, upto 24 hr post last dose

Study Arms (2)

MDT-637

EXPERIMENTAL

Active formulation

Drug: MDT-637

Placebo

PLACEBO COMPARATOR

Matched Placebo Comparator

Drug: MDT-637

Interventions

MDT-637DRUG

Inhaled doses of MDT-637 over a 10 day period

MDT-637

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Coast Clinical Trials

Cypress, California, United States

Location

Related Links

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

VP-14637

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2011

First Posted

December 9, 2011

Study Start

December 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

US(1)