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: NCT00210093
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 16, 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, intranasal, and inhalation administration and to calculate the relative bioavailability of INS37217 when administered via oral or nasal inhalation.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Crossover Pharmacokinetic Evaluation of the Effect of Single Doses of Intravenous INS37217, Nasally Inhaled INS37217 and Orally Inhaled INS37217 Solution in Healthy Volunteers
Study Start Date : April 2003
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Primary Outcome Measures :
  1. plasma concentrations of INS37217

Secondary Outcome Measures :
  1. Pilot study - not specified

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Ages Eligible for Study:   Child, Adult, Older Adult

Inclusion Criteria:

  • Are current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use
  • 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, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy
  • Subject with a physical obstruction in the nose
  • Use of concomitant medication other than hormonal contraceptives and multi-vitamins
  • Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness

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): NCT00210093

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Amy Schaberg, BSN

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00210093     History of Changes
Other Study ID Numbers: 08-106
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015