Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-04-10 @ 2:25 AM
Study NCT ID:
NCT01690351
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2012-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000618268', 'term': 'PF-05089771'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2012-09-18', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)', 'timeFrame': 'days 1-2'}, {'measure': 'AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)', 'timeFrame': 'days 1-2'}, {'measure': 'AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)', 'timeFrame': 'days 1-2'}, {'measure': 'Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)', 'timeFrame': 'days 1-2'}, {'measure': 't½ = Elimination half life of PF-05089771 (hr)', 'timeFrame': 'days 1-2'}], 'secondaryOutcomes': [{'measure': 'evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.', 'timeFrame': 'days 1-2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3291015&StudyName=A%20Study%20Comparing%20PF-05089771%20TS%20Capsule%20To%20PF-05089771%20TS%20Oral%20Dispersion%20In%20The%20Fasted%20State%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years\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* Any condition possibly affecting drug absorption (eg, gastrectomy).\n* A positive urine drug screen.\n* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.\n* Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.\n* Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc \\>450 msec or a QRS interval \\>120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds \\>120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility."}, 'identificationModule': {'nctId': 'NCT01690351', 'briefTitle': 'A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Oral Dispersion To PF-05089771 TS Capsule', 'orgStudyIdInfo': {'id': 'B3291015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-05089771 Oral Dispersion fasted', 'description': 'Oral dispersion TS formulation- fasted', 'interventionNames': ['Drug: PF-05089771']}, {'type': 'EXPERIMENTAL', 'label': 'PF-05089771 TS formulation fasted', 'description': 'Capsules TS formulation- fasted', 'interventionNames': ['Drug: PF-05089771']}], 'interventions': [{'name': 'PF-05089771', 'type': 'DRUG', 'description': 'Oral dispersion TS formulation- fasted', 'armGroupLabels': ['PF-05089771 Oral Dispersion fasted']}, {'name': 'PF-05089771', 'type': 'DRUG', 'description': 'Capsules TS formulation- fasted', 'armGroupLabels': ['PF-05089771 TS formulation fasted']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-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': {'type': 'SPONSOR'}}}}