Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT01161069
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2010-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549061', 'term': '3-(4-(2-hydroxyethyl)piperazin-1-yl)-7-(6-methoxypyridin-3-yl)-1-(2-propoxyethyl)pyrido(3,4-b)pyrazin-2(1H)-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-08', 'studyFirstSubmitDate': '2010-05-07', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety laboratory assessments, vital signs (including supine and standing blood pressure), physical examination, 12-lead ECGs and adverse events.', 'timeFrame': 'Days 1 through 14'}, {'measure': 'PK Parameters:Day 1: Area under concentration time curve from hour 0 to the last dosing interval (AUCtau), maximum observed concentration (Cmax), and time of maximum observed concentration (Tmax), for PF-03049423 in plasma.', 'timeFrame': 'Day 1'}, {'measure': 'PK Parameters: Day 14: Cmax at steady state, Tmax, AUCtau at steady state , t½, Cavg at steady state, Cmin at steady state, Cmax at steady state /Cmax sd, AUCtau at steady state/ AUCtau sd, Ae% and CLr.', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Days 1 to 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['phase 1', 'healthy young adult volunteers', 'healthy elderly adult volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9541002&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%20And%20Tolerability%20Of%20Different%20Doses%20Of%20PF-03049423%20In%20Healthy%20Adult%20Volunteers%20And%20Healthy%20Older%20Volunt', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423 after multiple dose administration to healthy young adult volunteers and healthy elderly volunteers. The study will also explore the relationship between blood pressure (supine and standing) and PF-03049423 concentration.', 'detailedDescription': 'The purpose of the investigation is to evaluate the safety and tolerability of an investigational new drug, PF-03049423, when dosed for two weeks in both healthy younger and healthy older subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy persons, male or female.\n* For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive.\n* For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive.\n* Body Mass Index (BMI) of 18 to 35; and a total body weight \\>50 kg (110 lbs)\n\nExclusion Criteria:\n\n* Subjects with clinically significant medical conditions.\n* Women of non-child bearing potential.\n* Subjects with a known medical history of hearing loss/disability or nonarteritic ischemic optic neuropathy.\n* A positive urine drug screen.'}, 'identificationModule': {'nctId': 'NCT01161069', 'briefTitle': 'A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Toleration, Pharmacokinetics Of PF-03049423 In Healthy Young Adult Volunteers And Healthy Elderly Volunteers', 'orgStudyIdInfo': {'id': 'A9541002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PF-03049423', 'description': 'Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers', 'interventionNames': ['Drug: PF-03049423']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Drug', 'description': 'Placebo in oral solution, given once daily for 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-03049423', 'type': 'DRUG', 'description': 'PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers', 'armGroupLabels': ['PF-03049423']}, {'name': 'PF-03049423', 'type': 'DRUG', 'description': 'PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers', 'armGroupLabels': ['PF-03049423']}, {'name': 'PF-03049423', 'type': 'DRUG', 'description': 'PF-03049423 in oral solution, 6 mg, given once daily for 7 days, then 12 mg given once daily for 7 days; healthy young adult volunteers', 'armGroupLabels': ['PF-03049423']}, {'name': 'PF-03049423', 'type': 'DRUG', 'description': 'PF-03049423 in oral solution, 3 mg, given once daily for 7 days, then 6 mg given once daily for 7 days; healthy elderly adult volunteers', 'armGroupLabels': ['PF-03049423']}, {'name': 'PF-03049423', 'type': 'DRUG', 'description': 'PF-03049423 in oral solution, 5 mg, given once daily for 7 days, then 10 mg given once daily for 7 days; healthy elderly adult volunteers', 'armGroupLabels': ['PF-03049423']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo in oral solution, given once daily for 14 days', 'armGroupLabels': ['Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}