Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT01147432
Status:
COMPLETED
Last Update Posted:
2011-12-21
First Post:
2010-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Response Capsaicin Flare Study
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']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-19', 'studyFirstSubmitDate': '2010-06-16', 'studyFirstSubmitQcDate': '2010-06-17', 'lastUpdatePostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin', 'timeFrame': '7 weeks post first dose'}], 'secondaryOutcomes': [{'measure': 'Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety', 'timeFrame': '12 weeks post final dose'}, {'measure': 'Plasma concentrations of free PF-04427429', 'timeFrame': '6 weekly following week 15'}, {'measure': 'Plasma concentrations of free and total CGRP', 'timeFrame': '6 weekly following week 15'}, {'measure': 'Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.', 'timeFrame': '7 weeks post first dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy male volunteers', 'capsaicin challenge', 'safety', 'toleration'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0141006&StudyName=Acute%20Response%20Capsaicin%20Flare%20Study%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways. This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response.', 'detailedDescription': 'Proof of mechanism in healthy volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects between the ages of 18 and 50 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* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.\n* Skintype I-III with a distance from base of scaphoid to antecubital fossa \\>26cm on their forearms.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).\n* Use of biologics including any live vaccines within 3 months prior to screening or prior treatment with an antibody in a previous clinical trial or treatment with an immunoglobulin in the past 6 months.\n* 12-lead ECG demonstrating QTcF \\>450 msec at screening.\n* Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessive hairy volar forearms.'}, 'identificationModule': {'nctId': 'NCT01147432', 'briefTitle': 'Acute Response Capsaicin Flare Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Modified Cross-Over Study To Examine The Acute Effect Of PF-04427429 On Capsaicin Flare Response In Healthy Volunteers Using EMLA Cream As Positive Control', 'orgStudyIdInfo': {'id': 'B0141006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04427429', 'interventionNames': ['Drug: PF-04427429', 'Other: Capsaicin challenge']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo', 'Other: Capsaicin challenge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EMLA', 'interventionNames': ['Other: EMLA positive control']}], 'interventions': [{'name': 'PF-04427429', 'type': 'DRUG', 'description': 'Single dose IV infusion up to 300mg', 'armGroupLabels': ['PF-04427429']}, {'name': 'Capsaicin challenge', 'type': 'OTHER', 'description': 'Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period', 'armGroupLabels': ['PF-04427429']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo IV infusion (saline) to be administered during two of the three treatment periods', 'armGroupLabels': ['Placebo']}, {'name': 'Capsaicin challenge', 'type': 'OTHER', 'description': 'Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period', 'armGroupLabels': ['Placebo']}, {'name': 'EMLA positive control', 'type': 'OTHER', 'description': '2g EMLA cream to be applied ONCE during study period 1', 'armGroupLabels': ['EMLA']}]}, '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'}}}}