A Pharmacokinetic Evaluation Study in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210054
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: denufosol tetrasodium (INS37217) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers
Study Start Date : November 2002
Primary Completion Date : December 2002
Study Completion Date : December 2002

Primary Outcome Measures :
  1. detection and characterization of plasma concentrations of INS37217

Secondary Outcome Measures :
  1. Pilot study - not specified

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210054

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Principal Investigator: Robin Deterding, MD

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00210054     History of Changes
Other Study ID Numbers: 08-105
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015