Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT01205867
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2010-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537417', 'term': 'Butyrylcholinesterase deficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609563', 'term': 'AZD8848'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2010-09-20', 'studyFirstSubmitQcDate': '2010-09-20', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose', 'timeFrame': 'Immediately prior to administration of the IP (Day 0)'}, {'measure': 'Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose', 'timeFrame': 'Repeated assessments during Day 1.'}, {'measure': 'Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose', 'timeFrame': 'Repeated assessments during Day 2.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine)', 'timeFrame': 'Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.'}, {'measure': 'Pharmacodynamics (IL-1Ra in plasma)', 'timeFrame': 'Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Butyrylcholinesterase deficiency', 'tolerability', 'safety', 'AZD8848', 'pharmacokinetics', 'pharmacodynamics', 'BChE deficient subjects and matched control subject'], 'conditions': ['Butyrylcholinesterase Deficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1658&filename=D0540C00009_Study_Synopsis.PDF', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects.', 'detailedDescription': 'An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to Sex and Age matched Controls'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BChE deficient subjects: The half-live of AZD8848 in plasma should be more than 20 minutes in an in vitro screening test\n* Matched control subject: The half-live of AZD8848 in plasma should be less than 2 minutes in an in vitro screening test\n\nExclusion Criteria:\n\n* Any clinically relevant abnormal findings in physical examination, laboratory assessments, vital signs or ECG\n* Present or medical history of cardiovascular disease which, in the opinion of the investigator, may either put subject at risk because of participation in the study or influence the result of the study or the subject's ability to participate in the study\n* Family history of autoimmune disease"}, 'identificationModule': {'nctId': 'NCT01205867', 'briefTitle': 'Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase Deficient Subjects and to Sex and Age Matched Controls', 'orgStudyIdInfo': {'id': 'D0540C00009'}, 'secondaryIdInfos': [{'id': 'EUDract No: 2010-019434-27'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD8848 given to BChE deficient subjects and age \\& gender matched control subjects', 'interventionNames': ['Drug: AZD8848']}], 'interventions': [{'name': 'AZD8848', 'type': 'DRUG', 'description': 'Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jesper Sonne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DanTrials ApS, Copenhagen, Denmark'}, {'name': 'Sam Lindgren, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Lund, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}