Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT00687232
Status:
COMPLETED
Last Update Posted:
2010-12-01
First Post:
2008-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers
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': 'C546512', 'term': 'AZD-4818'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2008-05-28', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry', 'timeFrame': 'During the study'}, {'measure': 'Lab assessment', 'timeFrame': 'During the study'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'During the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I', 'Japan', 'Japanese', 'inhalation'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* Body Mass Index (BMI) between 18.0-27.0 kg/m2\n* No clinically relevant abnormal findings\n\nExclusion Criteria:\n\n* Acute illness which requires medical intervention\n* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.\n* Clinical relevant disease or disorder (past or present)\n* A history of respiratory disorders'}, 'identificationModule': {'nctId': 'NCT00687232', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Placebo-controlled Single-blind, Single-centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers', 'orgStudyIdInfo': {'id': 'D3540C00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD4818', 'interventionNames': ['Drug: AZD4818']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD4818', 'type': 'DRUG', 'description': 'Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Michio Yagi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osaka Pharmacology Clinical Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Bengt Larsson/MD PhD, Medical Science Director, RITA EPT2', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}