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: November 8, 2013
Last verified: November 2013
  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
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: November 8, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014