A Pharmacokinetic Evaluation Study in Healthy Volunteers

NCT ID: NCT00210054

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2002-12-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

denufosol tetrasodium (INS37217)

Intervention Type: DRUG

Eligibility Criteria

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

• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin Deterding, MD

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

08-105

Identifier Type: -

Identifier Source: org_study_id