Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT00856258
Status:
TERMINATED
Last Update Posted:
2009-12-23
First Post:
2009-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-22', 'studyFirstSubmitDate': '2009-03-03', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single Dose PK: Cmax, Tmax, and AUCtau; Multiple Dose PK (Assumed Steady State): Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd).', 'timeFrame': '13 days'}, {'measure': 'Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, and electrocardiograms (ECGs).', 'timeFrame': '13 days'}], 'secondaryOutcomes': [{'measure': 'Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10.', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple dose in healthy volunteers'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0171002&StudyName=Multiple%20dose%20study%20in%20healthy%20volunteers%20to%20assess%20safety%2C%20pharmacokinetics%20and%20pharmacodynamics%20of%20PF%2003882845', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.', 'detailedDescription': 'The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.\n* An informed consent document signed and dated by the subject or a legally acceptable representative.\n* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant disease, allergy or clinical findings at screening.\n* A positive urine drug screen, history of significant regular alcohol consumption within 6 months of screening or use of tobacco or nicotine containing products within the three months preceding study date or a positive urine cotinine at screening or Day -3.\n* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.\n* Pregnant or nursing females; females of childbearing potential.'}, 'identificationModule': {'nctId': 'NCT00856258', 'briefTitle': 'Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Double Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Oral Multiple Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF 03882845 In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B0171002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 1', 'description': 'Cohort 1 completed.', 'interventionNames': ['Drug: PF 03882845 and Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 2', 'description': 'Cohort 2 not studied', 'interventionNames': ['Drug: PF 03882845 and Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 3', 'description': 'Cohort 3 not studied', 'interventionNames': ['Drug: PF 03882845 and Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 4', 'description': 'Cohort 4 not studied', 'interventionNames': ['Drug: PF 03882845 and Placebo']}], 'interventions': [{'name': 'PF 03882845 and Placebo', 'type': 'DRUG', 'description': 'The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.', 'armGroupLabels': ['Cohort 1']}, {'name': 'PF 03882845 and Placebo', 'type': 'DRUG', 'description': 'The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.', 'armGroupLabels': ['Cohort 2']}, {'name': 'PF 03882845 and Placebo', 'type': 'DRUG', 'description': 'The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.', 'armGroupLabels': ['Cohort 3']}, {'name': 'PF 03882845 and Placebo', 'type': 'DRUG', 'description': 'The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.', 'armGroupLabels': ['Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], '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.'}}}}