Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 1:29 PM
Study NCT ID:
NCT01311635
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2011-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioavailability Study Comparing 3 Different AZD1981 Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C569518', 'term': 'AZD1981'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-06', 'studyFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981', 'timeFrame': 'Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.'}], 'secondaryOutcomes': [{'measure': 'To evaluate basic systemic PK parameters as follows:', 'timeFrame': 'PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period', 'description': '* AUC(0-t): area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration\n* tmax: time to reach Cmax\n* t1/2λz: terminal half-life\n* CL/F: apparent plasma clearance\n* MRT: apparent mean residence time\n* Vz/F: apparent volume of distribution during terminal phase'}, {'measure': 'To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight', 'timeFrame': 'Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study'}]}, 'conditionsModule': {'keywords': ['Phase 1', 'bioavailability study', 'AZD1981', 'tablets', 'To study the relative bioavailability of single dose AZD1981 via three different tablets', 'To compare the bioavailability between three different AZD1981 tablets'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive\n* Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive\n* Be a non-smoker or ex-smoker who has stopped smoking for \\>6 months prior to screening\n* Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.\n\nExclusion Criteria:\n\n* Any clinically significant disease or disorder\n* Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2\n* Prolonged QTcF \\>450 ms or shortened QTcF\\<340 ms at Visit 1 or family history of long QT syndrome\n* History of, or current alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT01311635', 'briefTitle': 'A Bioavailability Study Comparing 3 Different AZD1981 Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open Label, Randomised, 4-way Crossover Study to Investigate the Relative Bioavailability of Single Dose AZD1981 Via 3 Different Tablets in Healthy Men and Healthy Women of Non-childbearing Potential', 'orgStudyIdInfo': {'id': 'D9830C00020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'interventionNames': ['Drug: AZD1981, current small-particle tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'interventionNames': ['Drug: AZD1981, new small-particle tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'interventionNames': ['Drug: AZD1981, new small-particle tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'interventionNames': ['Drug: AZD1981, new large-particle table']}], 'interventions': [{'name': 'AZD1981, current small-particle tablet', 'type': 'DRUG', 'description': '3x100 mg per oral, single dose in fasted state', 'armGroupLabels': ['Treatment A']}, {'name': 'AZD1981, new small-particle tablet', 'type': 'DRUG', 'description': '3x100 mg per oral, single dose', 'armGroupLabels': ['Treatment B', 'Treatment C']}, {'name': 'AZD1981, new large-particle table', 'type': 'DRUG', 'description': '3x100 mg per oral, single dose in fasted state', 'armGroupLabels': ['Treatment D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Wolfgang Kühn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles AB, Phase 1 Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Christer Hultquist / MD', 'oldOrganization': 'AstraZeneca R&D'}}}}