A Pharmacokinetic Evaluation Study in Healthy Volunteers

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: denufosol tetrasodium (INS37217)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00210093

08-106

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Volunteers

No Healthy Volunteers

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