Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 2:47 PM
Study NCT ID:
NCT00914433
Status:
WITHDRAWN
Last Update Posted:
2012-12-03
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Drug development suspended', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-30', 'studyFirstSubmitDate': '2009-06-02', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway-specific and general safety and tolerability.', 'timeFrame': '24 hours post-dose and on Day 4'}], 'secondaryOutcomes': [{'measure': 'Effect on mRNA', 'timeFrame': '24 hrs post-dose and on Day 4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study will look at the safety and tolerability of TPI 1100 in healthy volunteers and look at pharmacodynamic (PD) effect on mRNA expression of PDE 4B/D \\& 7A in blood and in sputum.', 'detailedDescription': 'Study was not initiated and terminated before start-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, male or female volunteers aged 18 to 55 years inclusive\n* Screening/baseline FEV1 greater than 90% predicted,\n* Body mass index (BMI) of 19 to 28 inclusive,\n* Clinical laboratory values and/or vital signs within normal reference ranges or not considered clinically significant by the Investigator\n\nExclusion Criteria:\n\n* Airways or systemic conditions that might affect respiratory function, including but not limited to clinically significant cardiac problems,\n* Breast-feeding or pregnancy,\n* Positive tests for smoking tobacco, alcohol, hepatitis B-surface antigen, hepatitis C antibody, and HIV at screening,\n* History of serious adverse reaction to any drugs,'}, 'identificationModule': {'nctId': 'NCT00914433', 'briefTitle': 'Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syntara'}, 'officialTitle': 'A Phase 1,Randomized, Double--blind, Placebo-controlled Study Assessing the Safety and Tolerability, the Pharmacodynamics and Pharmacokinetics of Single-ascending and Repeated Doses of Inhaled TPI 1100 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'TPI 1100-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TPI 1100', 'description': 'Drug to be given by inhalation.', 'interventionNames': ['Drug: TPI 1100']}], 'interventions': [{'name': 'TPI 1100', 'type': 'DRUG', 'description': '1 dose only increasing dose', 'armGroupLabels': ['TPI 1100']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pageau', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Topigen Pharmaceuticals Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syntara', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}