NCT00210093

Brief Summary

The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous, intranasal, and inhalation administration and to calculate the relative bioavailability of INS37217 when administered via oral or nasal inhalation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_1 healthy

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

April 1, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

September 13, 2005

Last Update Submit

October 15, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • plasma concentrations of INS37217

Secondary Outcomes (1)

  • Pilot study - not specified

Interventions

denufosol tetrasodium (INS37217)DRUG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Are current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use
  • Are within 20% of their ideal body weight
  • Are healthy on the basis of a pre-trial physical examination

You may not qualify if:

  • History or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
  • History of cardiac arrhythmias, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy
  • Subject with a physical obstruction in the nose
  • Use of concomitant medication other than hormonal contraceptives and multi-vitamins
  • Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

denufosol tetrasodium

Study Officials

  • Amy Schaberg, BSN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2003

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

October 16, 2015

Record last verified: 2015-10