NCT01355016

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

May 11, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

May 11, 2011

Last Update Submit

April 10, 2012

Conditions

Drug SafetyRespiratory Syncytial Virus Infections

Keywords

RSV

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Plasma pharmacokinetics for MDT-637 dry powder inhalation

    Multiple plasma samples collected up to 24 hours post first dose

  • Trough MDT-637 Nasal Concentration

    24 hours

  • Plasma pharmacokinetics for MDT-637 dry powder inhalation

    24 hours

  • Plasma pharmacokinetics of MDT-637 dry powder inhalation

    24 hours

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 24 hour period

MDT-637Placebo

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, 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Coast Clinical Trials

Cypress, California, 90630, 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

Study Record Dates

First Submitted

May 11, 2011

First Posted

May 17, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

US(1)