Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-26 @ 6:18 AM
Study NCT ID:
NCT00210093
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Evaluation Study in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C465279', 'term': 'denufosol tetrasodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-15', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma concentrations of INS37217'}], 'secondaryOutcomes': [{'measure': 'Pilot study - not specified'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Are within 20% of their ideal body weight\n* Are healthy on the basis of a pre-trial physical examination\n\nExclusion Criteria:\n\n* History or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening\n* History of cardiac arrhythmias, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy\n* Subject with a physical obstruction in the nose\n* Use of concomitant medication other than hormonal contraceptives and multi-vitamins\n* Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness'}, 'identificationModule': {'nctId': 'NCT00210093', 'briefTitle': 'A Pharmacokinetic Evaluation Study in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '08-106'}}, 'armsInterventionsModule': {'interventions': [{'name': 'denufosol tetrasodium (INS37217)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amy Schaberg, BSN', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}