Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT00810758
Status:
COMPLETED
Last Update Posted:
2009-12-01
First Post:
2008-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
Sponsor:
Organization:
Raw JSON
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total body weight \\>50kg (110lbs).\n\nExclusion Criteria:\n\n* Pregnant or nursing females.\n* Females of child-bearing potential.\n* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening.\n* Smoking within the previous 6 months.'}, 'identificationModule': {'nctId': 'NCT00810758', 'briefTitle': 'Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized, Placebo Controlled, Blinded (3rd Party Open), Sequential, Multiple-Dose Escalation Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691 In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B1201002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04878691', 'interventionNames': ['Drug: PF-04878691 3mg', 'Drug: PF-04878691 6mg', 'Drug: PF-04878691 9mg']}], 'interventions': [{'name': 'PF-04878691 3mg', 'type': 'DRUG', 'description': 'Oral solution, 3mg, twice weekly, 2 weeks', 'armGroupLabels': ['PF-04878691']}, {'name': 'PF-04878691 6mg', 'type': 'DRUG', 'description': 'Oral solution, 6mg, twice weekly, 2 weeks', 'armGroupLabels': ['PF-04878691']}, {'name': 'PF-04878691 9mg', 'type': 'DRUG', 'description': 'Oral solution, 9mg, twice weekly, 2 weeks', 'armGroupLabels': ['PF-04878691']}]}, '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.'}}}}