Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 10:43 PM
Study NCT ID:
NCT01051232
Status:
COMPLETED
Last Update Posted:
2010-04-26
First Post:
2010-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-22', 'studyFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2010-01-14', 'lastUpdatePostDateStruct': {'date': '2010-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety; ECGs/vital signs', 'timeFrame': 'Screening to Follow-up (Day 5)'}, {'measure': 'Safety; laboratory tests', 'timeFrame': 'Screening to Follow-up (Day 5)'}, {'measure': 'Safety; physical examination/adverse event monitoring', 'timeFrame': 'Screening to Follow-up (Day 5)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations', 'timeFrame': 'Day 1 to Day 3'}, {'measure': 'Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations', 'timeFrame': 'Day 1 to Day 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['filibuvir', 'pharmacokinetics', 'Japanese', 'Asian'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8121035&StudyName=A%20Study%20To%20Investigate%20Safety%20And%20Pharmacokinetics%20Of%20A%20Single%20Dose%20Of%20PF-00868554%20%28Filibuvir%29%20In%20Japanese%20Healthy%20Adult%20Volunteers', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.', 'detailedDescription': 'Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects between the ages of 20 and 55 years.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg.\n\nExclusion Criteria:\n\n* A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.\n* Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.\n* Pregnant or nursing females; females of childbearing potential.'}, 'identificationModule': {'nctId': 'NCT01051232', 'briefTitle': 'A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double Blind, Placebo-Controlled, Randomized, Dose Escalation Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 (Filibuvir) Following Single Oral Administrations Of PF-00868554 (Filibuvir) Under Fasting Conditions In Japanese Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'A8121035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 1', 'description': 'PF-00868554 (filibuvir) 100 mg or placebo', 'interventionNames': ['Drug: Active', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 2', 'description': 'PF-00868554 (filibuvir) 300 mg or placebo', 'interventionNames': ['Drug: Active', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 3', 'description': 'PF-00868554 (filibuvir) 500 mg or placebo', 'interventionNames': ['Drug: Active', 'Drug: Placebo']}], 'interventions': [{'name': 'Active', 'type': 'DRUG', 'description': 'Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.', 'armGroupLabels': ['Cohort 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Two subjects will receive the placebo under fasting condition.', 'armGroupLabels': ['Cohort 1']}, {'name': 'Active', 'type': 'DRUG', 'description': 'Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.', 'armGroupLabels': ['Cohort 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Two subjects will receive the placebo under fasting condition.', 'armGroupLabels': ['Cohort 2']}, {'name': 'Active', 'type': 'DRUG', 'description': 'Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.', 'armGroupLabels': ['Cohort 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Two subjects will receive the placebo under fasting condition.', 'armGroupLabels': ['Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}], '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.'}}}}