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

NCT00210054

08-105

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)