Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-29 @ 11:20 AM
Study NCT ID:
NCT01037504
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2009-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD5423 Multiple Ascending Dose Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587250', 'term': '2,2,2-trifluoro-N-(1-((1-(4-fluorophenyl)-1H-indazol-5-yl)oxy)-1-(3-methoxyphenyl)-2-propanyl)acetamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2009-12-20', 'studyFirstSubmitQcDate': '2009-12-22', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety variables: adverse events', 'timeFrame': 'Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics profile: concentration of AZD5423 in plasma', 'timeFrame': 'Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints.'}, {'measure': 'Investigation of PD effects', 'timeFrame': 'Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety', 'tolerability', 'healthy', 'inhalation', 'Healthy volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1255&filename=D2340C00002.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated, written informed consent prior to any study specific procedures\n* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg\n\nExclusion Criteria:\n\n* Any clinically significant disease or disorder\n* Any clinically significant abnormalities at screening examination\n* Use of any prescribed or non-prescribed medication'}, 'identificationModule': {'nctId': 'NCT01037504', 'briefTitle': 'AZD5423 Multiple Ascending Dose Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'D2340C00002'}, 'secondaryIdInfos': [{'id': 'EudraCT No: 2009-016611-38'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Drug: AZD5423', 'interventionNames': ['Drug: AZD5423']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Drug: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD5423', 'type': 'DRUG', 'description': 'Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London Bridge', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'Darren Wilbraham', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Quintiles Drug Research Unit at Guy's Hospital, London, UK"}, {'name': 'Jorup Carin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Lund, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}