A Pharmacokinetic Evaluation Study in Healthy Volunteers

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

Completed

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Key information

Conditions

Healthy

Study type

Interventional

Phase

Phase 1

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

denufosol tetrasodium (INS37217)

Drug

Primary outcomes

detection and characterization of plasma concentrations of INS37217

Secondary outcomes

Pilot study - not specified

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers

Important dates

Study start: 2002
Primary completion: 2002
Study completion: 2002
First posted: Sep 21, 2005
Registry last updated: Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed