A Pharmacokinetic Evaluation Study in Healthy Volunteers

NCT ID: NCT00210093

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2003-05-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

denufosol tetrasodium (INS37217)

Intervention Type: DRUG

Eligibility Criteria

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

• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Schaberg, BSN

Role: STUDY_DIRECTOR

Other Identifiers

08-106

Identifier Type: -

Identifier Source: org_study_id