Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT01016951
Status:
TERMINATED
Last Update Posted:
2010-11-19
First Post:
2009-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Subjects and in Patients With Chronic Obstructive Pulmonary Disease
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'whyStopped': 'Study stopped since it was considered that one of the pre-defined stopping criterion was met.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-18', 'studyFirstSubmitDate': '2009-11-19', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)", 'timeFrame': 'Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics samples for AZD9164', 'timeFrame': 'PK sampling during the residential period and intense PK sampling day 1 and 15 in healthy and day 13 in COPD patients'}, {'measure': 'Investigation of PD effects', 'timeFrame': 'Spirometry at screening and during the residential stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I', 'Safety study', 'AZD9164'], 'conditions': ['Healthy', 'COPD']}, 'referencesModule': {'references': [{'pmid': '24669829', 'type': 'DERIVED', 'citation': 'Jorup C, Bengtsson T, Strandgarden K, Sjobring U. Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. BMC Pulm Med. 2014 Mar 27;14:52. doi: 10.1186/1471-2466-14-52.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled AZD9164 following administration of multiple ascending doses in healthy male and female subjects and COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and female, age 18-45, COPD patients \\> 40 years\n* Healthy subjects and COPD patients; Provision of signed and dated, written informed consent prior to any study specific procedures\n* Healthy subjects; Females must have a negative pregnancy test, must not be lactating and must be of non-child-bearing potential, by the following criteria: - irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy\n* COPD patients; Females must have a negative pregnancy test, must not be lactating and must be of non-child-bearing potential, by the following criteria: Post menopausal. Woman below 50 years old will be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments, and with LH and FSH levels in the post menopausal range. Women over 50 years of age will be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. - irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy\n* Healthy subjects; Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg\n* COPD patients; Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg\n\nExclusion Criteria:\n\n* Healthy subjects; Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study\n* COPD patients; Any clinically significant disease or disorder (other than COPD) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study\n* Healthy subject and COPD patients; Any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigator\n* Healthy subject and COPD patients; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes"}, 'identificationModule': {'nctId': 'NCT01016951', 'briefTitle': 'A Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Subjects and in Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD9164 Given Once Daily as Inhaled Formulation Via Turbuhaler for 13 Days in Healthy Male and Female Subjects and in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'D1882C00002'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2009-015645-23'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'AZD9164', 'interventionNames': ['Drug: AZD9164 Turbuhaler®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo Turbuhaler®']}], 'interventions': [{'name': 'AZD9164 Turbuhaler®', 'type': 'DRUG', 'description': 'Dry powder for inhalation via Turbuhaler, MAD. Starting dose in healthy volunteers is 400 µg with up to two dose escalations not exceeding AstraZeneca pre-defined exposure limits.\n\nThe COPD patients will receive a dose of 1000 µg.', 'armGroupLabels': ['A']}, {'name': 'Placebo Turbuhaler®', 'type': 'DRUG', 'description': 'Dry powder for inhalation via Turbuhaler, MAD', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Luleå', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}], 'overallOfficials': [{'name': 'Carin Jorup', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Lund, Sweden'}, {'name': 'Aslak Rautio', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles Hermelinen AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Carin Jorup MD, Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}