A Pharmacokinetic Evaluation Study in Healthy Volunteers

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.

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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 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

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, 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

Treatment and study plan

denufosol tetrasodium (INS37217)

Drug

Primary outcomes

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

A Single-Center, Randomized, Crossover Pharmacokinetic Evaluation of the Effect of Single Doses of Intravenous INS37217, Nasally Inhaled INS37217 and Orally Inhaled INS37217 Solution in Healthy Volunteers

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Sep 21, 2005
Registry last updated: Oct 16, 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