A Pharmacokinetic Evaluation Study in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: denufosol tetrasodium (INS37217)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
plasma concentrations of INS37217

Secondary Outcome Measures

Outcome Measure
Pilot study - not specified

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): May 1, 2003
• Study Completion (Actual): May 1, 2003

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 15, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 08-106