Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-09 @ 7:51 PM
Study NCT ID:
NCT00971802
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2009-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C552104', 'term': '(3S,3aR)-2-(3-chloro-4-cyanophenyl)-3-cyclopentyl-3,3a,4,5-tetrahydro-2H-benzo(g)indazole-7-carboxylic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-22', 'studyFirstSubmitDate': '2009-09-03', 'studyFirstSubmitQcDate': '2009-09-03', 'lastUpdatePostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single-Dose PK for PF-03382845: 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 of PF-03382845 as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, electrocardiograms (ECGs) and potential sex hormone mediators.', 'timeFrame': '13 days'}], 'secondaryOutcomes': [{'measure': 'Area under the effect curve (AUEC) for serum aldosterone and PRA on Day 0 and on Days 1 and 10 after administration of PF-03882845', 'timeFrame': '11 days'}, {'measure': 'Change from baseline(Day 0) to Day8 in exploratory mRNA gene expression biomarkers (SGK1:Sodium-and Serum/glucocorticoid regulated kinase 1 gene,ENaCα:Epithelial Sodium Channel alpha subunit,ENaCγ:Epithelial Sodium Channel gamma', 'timeFrame': '9 days'}, {'measure': 'subunit,MR: Mineral corticoid Receptor,ACTβ:Beta Actin) after administration of PF-03882845 or placebo.These results will not be included in the study report', 'timeFrame': '9 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0171008&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%2C%20And%20Pharmacodynamics%20Of%20PF-03882845%20In%20Healthy%20Volunteers', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of PF-03882845 in Healthy Volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\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.\n* Past medical history of epididymitis, orchitis, sexually transmitted diseases (chlamydia, gonorrhea, etc.) or urinary tract infection.\n* History of prostatitis or prostate surgery.\n* Urinary catheterization or instrumentation within 12 months of screening. Inguinal or scrotal hernia.\n* Current or history of congenital genital abnormalities.\n* Baseline scrotal ultrasound scan showing unilateral or bilateral scrotal blood flow abnormalities or anatomic abnormalities (hydrocele, cysts, other), with the exception of small epididymal cysts and spermatoceles.\n* Any condition possibly affecting drug absorption (eg, gastrectomy).\n* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.\n* History of sensitivity to spironolactone, eplerenone, or related compounds.\n* Serum potassium \\>5.5 mEq/L at screening or Day 0.'}, 'identificationModule': {'nctId': 'NCT00971802', 'briefTitle': 'A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers', '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': 'B0171008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Healthy volunteers - PF-03882845 versus Placebo', 'interventionNames': ['Drug: PF-03882845 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Healthy volunteers - PF-03882845 versus Placebo', 'interventionNames': ['Drug: PF-03882845 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Healthy volunteers - PF-03882845 versus Placebo', 'interventionNames': ['Drug: PF-03882845 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'Healthy volunteers - PF-03882845 versus Placebo', 'interventionNames': ['Drug: PF-03882845 or Placebo']}], 'interventions': [{'name': 'PF-03882845 or Placebo', 'type': 'DRUG', 'description': 'PF-03882845 20 mg or Placebo, daily for 10 days.', 'armGroupLabels': ['Cohort 1']}, {'name': 'PF-03882845 or Placebo', 'type': 'DRUG', 'description': 'PF-03882845 60 mg or Placebo, daily for 10 days.', 'armGroupLabels': ['Cohort 2']}, {'name': 'PF-03882845 or Placebo', 'type': 'DRUG', 'description': 'PF-03882845 120 mg or Placebo, daily for 10 days.', 'armGroupLabels': ['Cohort 3']}, {'name': 'PF-03882845 or Placebo', 'type': 'DRUG', 'description': 'PF-03882845 185 mg or Placebo, daily for 10 days.', 'armGroupLabels': ['Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}], '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.'}}}}