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CompletedNCT00210093Updated Oct 16, 2015

A Pharmacokinetic Evaluation Study in Healthy Volunteers

A Phase 1 interventional study of denufosol tetrasodium (INS37217) in Healthy, sponsored by Merck Sharp & Dohme LLC. Completed. Per ClinicalTrials.gov, last updated 2015-10-16.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)
06

What researchers measure

Primary outcomes

  1. plasma concentrations of INS37217

Secondary outcomes

  1. Pilot study - not specified

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00210093
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Apr 2003
Primary completion
May 2003
Completion
May 2003
Last update
Oct 16, 2015

Study contacts

Amy Schaberg, BSN
study director
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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