A Pharmacokinetic Evaluation Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00210093
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
plasma concentrations of INS37217

Secondary Outcome Measures

Name	Time	Method
Pilot study - not specified