Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-21 @ 5:56 AM
Study NCT ID:
NCT01247103
Status:
WITHDRAWN
Last Update Posted:
2010-12-01
First Post:
2010-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Safety and Pharmacokinetics of Single and Multiple Oral Doses of AZD4316 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2010-11-16', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'from screening period to follow-up'}, {'measure': 'Assesment of vital signs (blood pressure, pulse and temperature)', 'timeFrame': 'from screening period to follow-up', 'description': 'Frequent assessments will be made for each subject from the screening period to follow up'}, {'measure': 'Assessment of laboratory variables and physical examinations', 'timeFrame': 'from screening period to follow-up', 'description': 'Frequent assessments will be made for each subject from the screening period to follow up'}, {'measure': 'Assessment of Electrocardiogram (ECG) variables', 'timeFrame': 'from screening period to follow-up', 'description': 'Frequent assessments will be made for each subject from the screening period to follow up'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic variables of AZD4316 by assessment of drug concentrations in plasma and urine', 'timeFrame': 'Serial blood samples and urine collection for PK evaluation throughout the period of admission and up to the time of the follow-up visit'}]}, 'conditionsModule': {'keywords': ['healthy volunteers', 'safety', 'tolerability'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD4316 following oral administration of single and multiple doses to healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and female subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.\n* Female subjects must not be pregnant, must not be lactating and must be of non-child-bearing potential (i.e. they must be post-menopausal or surgically sterile)\n* Male subjects should be willing to use barrier contraception i.e. condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product\n* 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 inclusive.\n* Subjects who are healthy as determined by pre study medical history, physical examination, 12-Lead ECG\n\nExclusion Criteria:\n\n* History of 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 or the subject's ability to participate in the study.\n* Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG, including changes that may interfere with the interpretation of QTcF interval changes.\n* Current smokers, those who have smoked or used nicotine products within the previous three months.\n* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4316.\n* Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements."}, 'identificationModule': {'nctId': 'NCT01247103', 'briefTitle': 'Assessment of the Safety and Pharmacokinetics of Single and Multiple Oral Doses of AZD4316 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 1, Single-centre Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Dose, Parallel-group Study to Determine the Safety, Tolerability, and Pharmacokinetics of AZD4316 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D3340C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: single ascending dose', 'description': 'AZD4316: single oral dose, with 1 group with/without food', 'interventionNames': ['Drug: AZD4316', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: multiple ascending dose', 'description': 'AZD4316: multiple oral doses', 'interventionNames': ['Drug: AZD4316', 'Other: Placebo']}], 'interventions': [{'name': 'AZD4316', 'type': 'DRUG', 'description': 'Single oral doses of AZD4316 suspension in the fasted state. In one group in Part A, subjects will receive a second dose of AZD4316 in the fed state (within 30 min after receiving a high fat breakfast)', 'armGroupLabels': ['Part A: single ascending dose']}, {'name': 'AZD4316', 'type': 'DRUG', 'description': "Multiple oral doses of AZD4316 suspension. It's planned that doses will be administered in the fasted state, however, if in Part A it's shown that food increases absorption of AZD4316, then doses will be administered after a meal.", 'armGroupLabels': ['Part B: multiple ascending dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo to match AZD4316', 'armGroupLabels': ['Part A: single ascending dose', 'Part B: multiple ascending dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Dr Dereck Tait', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arrow Therapeutics'}, {'name': 'Dr Darren Wilbraham', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Science Director', 'oldOrganization': 'Arrow Therapeutics'}}}}