Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-01 @ 3:40 AM
Study NCT ID:
NCT01989520
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2013-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2013-11-15', 'studyFirstSubmitQcDate': '2013-11-15', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of pharmacokinetics of AZD5069 and its metabolite in terms of area under plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration and extrapolated to infinity (AUC(0-last) and AUC)', 'timeFrame': 'Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose', 'description': 'Curve taken during each of the 5 treatments'}, {'measure': 'Description of pharmacokinetics of AZD5069 and its metabolite in terms of observed maximum plasma concentration (Cmax), plasma concentration measured at 12 hours (C12h), Cmax/C12h ratio, Cmax/AUC ratio, terminal rate constant (λz)', 'timeFrame': 'Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose', 'description': 'Curve taken during each of the 5 treatments'}, {'measure': 'Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax)', 'timeFrame': 'Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose', 'description': 'Curve taken during each of the 5 treatments'}, {'measure': 'Description of pharmacokinetics of AZD5069 and its metabolite in terms of apparent systemic clearance (CL/F) (AZD5069 only), and apparent volume of distribution (Vz/F) (AZD5069 only)', 'timeFrame': 'Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose', 'description': 'Curve taken during each of the 5 treatments'}], 'secondaryOutcomes': [{'measure': 'Description of effect on neutrophils in terms of circulating neutrophil numbers reported as absolute circulating neutrophil counts (ANC). The minimum absolute neutrophil count (ANCmin) and the time to ANCmin (ANCtmin)', 'timeFrame': 'Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose', 'description': 'Samples taken during each of the 5 treatments'}, {'measure': 'Description of effect on neutrophils in terms of mean of ANC values from predose to 24 hours postdose (ANCmean), the minimum of the ANC ratio values (ANCmin,ratio)', 'timeFrame': 'Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose', 'description': 'Samples taken during each of the 5 treatments'}, {'measure': 'Description of effect on neutrophils in terms of the mean of ANC ratio values calculated baseline to 24 hours post dose (ANCmean,ratio)', 'timeFrame': 'Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose', 'description': 'Samples taken during each of the 5 treatments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relative bioavailability, Healthy volunteers, Neutrophils'], 'conditions': ['Uncontrolled and Persistent Asthma']}, 'referencesModule': {'references': [{'pmid': '29856004', 'type': 'DERIVED', 'citation': 'Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1889&filename=D3551C00002_Study_Synopsis.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'Study to investigate relative bioavailability of up to five different formulations of AZD5069', 'detailedDescription': 'An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male and/or female volunteers aged 18 to 50 years (inclusive).\n2. Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening.\n3. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) weight 50 kg and maximum (max) weight 100 kg.\n4. Healthy volunteers with neutrophil counts within the laboratory range at screening.\n\n \\-\n\nExclusion Criteria:\n\n1. A definite or suspected personal history of severe allergy, intolerance or hypersensitivity or ongoing allergy to drugs with a similar chemical structure or class to AZD5069 and/or the excipients, as judged to be clinically relevant by the Investigator.\n2. Healthy volunteers who have previously received AZD5069.\n3. Volunteers with latent tuberculosis as suggested by their history and judged by the Investigator; confirmatory testing with eg, Quantiferon(R) -TB Gold may be done if required.\n4. Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the IP -'}, 'identificationModule': {'nctId': 'NCT01989520', 'briefTitle': 'Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D3551C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'Phase IIb formulation', 'interventionNames': ['Drug: Phase IIb formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'Putative phase III formulation', 'interventionNames': ['Drug: Putative phase III formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'Slow dissolution variant 1', 'interventionNames': ['Drug: Slow dissolution variant 1']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'description': 'Slow dissolution variant 2', 'interventionNames': ['Drug: Slow dissolution variant 2']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment E', 'description': 'Optional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069', 'interventionNames': ['Drug: Test treatment E']}], 'interventions': [{'name': 'Phase IIb formulation', 'type': 'DRUG', 'description': 'Single oral dose 45mg AZD5069', 'armGroupLabels': ['Treatment A']}, {'name': 'Putative phase III formulation', 'type': 'DRUG', 'description': 'Single oral dose 45mg AZD5069', 'armGroupLabels': ['Treatment B']}, {'name': 'Slow dissolution variant 1', 'type': 'DRUG', 'description': 'Single oral dose 45mg AZD5069', 'armGroupLabels': ['Treatment C']}, {'name': 'Slow dissolution variant 2', 'type': 'DRUG', 'description': 'Single oral dose 45mg AZD 5069', 'armGroupLabels': ['Treatment D']}, {'name': 'Test treatment E', 'type': 'DRUG', 'description': 'Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069', 'armGroupLabels': ['Treatment E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Olufeyikemi Oluwayi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles London UK'}, {'name': 'Bengt Larssons, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astrazeneca Mölndal, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}