Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-27 @ 9:17 AM
Study NCT ID:
NCT01202266
Status:
TERMINATED
Last Update Posted:
2011-03-11
First Post:
2010-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Dose Study Of PF-05161704 In Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'The study was terminated on October 29, 2010 due to gastrointestinal adverse events.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-09', 'studyFirstSubmitDate': '2010-09-13', 'studyFirstSubmitQcDate': '2010-09-13', 'lastUpdatePostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring', 'timeFrame': '2 weeks'}, {'measure': 'Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL', 'timeFrame': '2 weeks'}, {'measure': 'Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Ascending Dose', 'Phase 1', 'Safety and Tolerability', 'PK', 'Healthy Subjects'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2911002&StudyName=A%20Multiple%20Dose%20Study%20Of%20PF-05161704%20In%20Healthy%20Volunteers', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive\n* Body Mass Index (BMI) of 24.5 to 35.5 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* Any condition possibly affecting drug absorption (e.g., gastrectomy).\n* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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* History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.'}, 'identificationModule': {'nctId': 'NCT01202266', 'briefTitle': 'A Multiple Dose Study Of PF-05161704 In Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B2911002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5 mg PF-05161704 or Placebo', 'interventionNames': ['Drug: PF-05161704 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': '15 mg PF-05161704 or Placebo', 'description': 'Planned dose: may be modified based on emerging PK and safety data.', 'interventionNames': ['Drug: PF-05161704 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': '50 mg PF-05161704 or Placebo', 'description': 'Planned dose: may be modified based on emerging PK and safety data.', 'interventionNames': ['Drug: PF-05161704 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': '150 mg PF-05161704 or Placebo', 'description': 'Planned dose: may be modified based on emerging PK and safety data.', 'interventionNames': ['Drug: PF-05161704 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'xx mg PF-05161704 or Placebo', 'description': 'Planned dose and dosing regimen will be determined based on emerging PK and safety data.', 'interventionNames': ['Drug: PF-05161704 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'xxx mg PF-05161704 or Placebo', 'description': 'Dose will be determined based on data from previous 5 arms.', 'interventionNames': ['Drug: PF-05161704 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'yy mg PF-05161704 or Placebo', 'description': 'Dose will be determined based on data from previous 6 arms', 'interventionNames': ['Drug: PF-05161704 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'yyy mg PF-05161704 or Placebo', 'description': 'Dose will be determined based on data from previous 7 arms.', 'interventionNames': ['Drug: PF-05161704 or Placebo']}], 'interventions': [{'name': 'PF-05161704 or Placebo', 'type': 'DRUG', 'description': 'PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner', 'armGroupLabels': ['5 mg PF-05161704 or Placebo']}, {'name': 'PF-05161704 or Placebo', 'type': 'DRUG', 'description': 'PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner', 'armGroupLabels': ['15 mg PF-05161704 or Placebo']}, {'name': 'PF-05161704 or Placebo', 'type': 'DRUG', 'description': 'PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner', 'armGroupLabels': ['50 mg PF-05161704 or Placebo']}, {'name': 'PF-05161704 or Placebo', 'type': 'DRUG', 'description': 'PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner', 'armGroupLabels': ['150 mg PF-05161704 or Placebo']}, {'name': 'PF-05161704 or Placebo', 'type': 'DRUG', 'description': 'PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast', 'armGroupLabels': ['xx mg PF-05161704 or Placebo']}, {'name': 'PF-05161704 or Placebo', 'type': 'DRUG', 'description': 'PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast', 'armGroupLabels': ['xxx mg PF-05161704 or Placebo']}, {'name': 'PF-05161704 or Placebo', 'type': 'DRUG', 'description': 'PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast', 'armGroupLabels': ['yy mg PF-05161704 or Placebo']}, {'name': 'PF-05161704 or Placebo', 'type': 'DRUG', 'description': 'PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast', 'armGroupLabels': ['yyy mg PF-05161704 or Placebo']}]}, '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.'}}}}