NCT00210054

Brief Summary

The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2002

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

November 1, 2002

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2.8 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 12, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

September 13, 2005

Last Update Submit

October 9, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • detection and characterization of 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 nonsmokers or those subjects whom have not smoked within 6 months
  • 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, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy
  • use of concomitant medication other than hormonal contraceptives and multi-vitamins
  • donation of blood in the 60 days preceding the screening visit
  • have been diagnosed with HIV, hepatitis B or hepatitis C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

denufosol tetrasodium

Study Officials

  • Robin Deterding, MD

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2002

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

October 12, 2015

Record last verified: 2015-10