Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-23 @ 4:10 AM
Study NCT ID:
NCT01959594
Status:
COMPLETED
Last Update Posted:
2014-03-28
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers
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']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-27', 'studyFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS.', 'timeFrame': '0-15 days'}, {'measure': 'Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR,', 'timeFrame': '0-15 days'}, {'measure': 'CogState at followup', 'timeFrame': '22-25 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple doses', 'pharmacokinetics', 'safety', 'tolerability', 'healthy volunteers', 'steady state', 'cognitive impairment associated with schizophrenia'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7441002&StudyName=A%20Study%20To%20Observe%20Safety%20And%20Blood%20Concentrations%20Of%20PF-06412562%20During%20And%20Following%20The%20Oral%20Administration%20Of%20Multiple%20Doses%20Of%20PF', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female subjects of non-childbearing potential and/or male subjects 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* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs);\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.'}, 'identificationModule': {'nctId': 'NCT01959594', 'briefTitle': 'A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of PF-06412562 In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B7441002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'interventionNames': ['Drug: 3 mg PF-06412562']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'interventionNames': ['Drug: 10 mg PF-06412562']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'interventionNames': ['Drug: 25 mg PF-06412562']}, {'type': 'EXPERIMENTAL', 'label': 'Optional Cohort 4', 'interventionNames': ['Drug: PF-06412562 TBD mg']}, {'type': 'EXPERIMENTAL', 'label': 'Optional Cohort 5', 'interventionNames': ['Drug: PF-06412562 TBD mg']}], 'interventions': [{'name': '3 mg PF-06412562', 'type': 'DRUG', 'description': 'oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days', 'armGroupLabels': ['Cohort 1']}, {'name': '10 mg PF-06412562', 'type': 'DRUG', 'description': 'oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days', 'armGroupLabels': ['Cohort 2']}, {'name': '25 mg PF-06412562', 'type': 'DRUG', 'description': 'oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days', 'armGroupLabels': ['Cohort 3']}, {'name': 'PF-06412562 TBD mg', 'type': 'DRUG', 'description': 'oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts', 'armGroupLabels': ['Optional Cohort 4']}, {'name': 'PF-06412562 TBD mg', 'type': 'DRUG', 'description': 'oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts', 'armGroupLabels': ['Optional Cohort 5']}]}, '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': {'type': 'SPONSOR'}}}}