A Pharmacokinetic Evaluation Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00210054
First received: September 13, 2005
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Healthy
Drug: denufosol tetrasodium (INS37217)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • detection and characterization of plasma concentrations of INS37217

Secondary Outcome Measures:
  • Pilot study - not specified

Enrollment: 4
Study Start Date: November 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210054

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00210054     History of Changes
Other Study ID Numbers: 08-105
Study First Received: September 13, 2005
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014