A Pharmacokinetic Evaluation Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00210054
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2002-12
• Study Completion: 2002-12
• 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: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

• are nonsmokers or those subjects whom have not smoked within 6 months
• 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, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy
• use of concomitant medication other than hormonal contraceptives and multi-vitamins
• donation of blood in the 60 days preceding the screening visit
• have been diagnosed with HIV, hepatitis B or hepatitis C

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
detection and characterization of plasma concentrations of INS37217

Secondary Outcome Measures

Name	Time	Method
Pilot study - not specified