Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT00844103
Status:
COMPLETED
Last Update Posted:
2009-04-30
First Post:
2009-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.
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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-29', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile: concentration of AZD8566 in blood', 'timeFrame': 'Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10'}, {'measure': 'Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events', 'timeFrame': 'Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile: concentration of AZD8566 in urine', 'timeFrame': 'Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Volunteer', 'Safety', 'Tolerability', 'AZD8566'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent.\n* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG\n* Females who are permanently or surgically sterile or postmenopausal and males.\n\nExclusion Criteria:\n\n* Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug\n* History of any convulsions or seizures\n* History of infection or at risk of infection due to recent surgery or trauma\n* History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug'}, 'identificationModule': {'nctId': 'NCT00844103', 'briefTitle': 'Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of AZD8566 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D1320C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD8566']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD8566', 'type': 'DRUG', 'description': '10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '10ml oral solution administered once a day over 10 days.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Macclesfield', 'state': 'Cheshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.26023, 'lon': -2.12564}}], 'overallOfficials': [{'name': 'Emeline Ramos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pharmacology Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Harsukh Parmar , Medical Science Director, Respiratory and Inflammation Emerging Product Team', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}