Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 12:39 PM
Study NCT ID:
NCT01320332
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2011-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-23', 'studyFirstSubmitDate': '2011-03-15', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic assessment through analysis of blood, fecal and urine samples', 'timeFrame': 'Up to Day 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulcerative colitis', 'ASP3291'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.', 'detailedDescription': 'After an 11-day screening period, subjects check into a clinic, are dosed on Day 1 and stay in the clinic for 4 days to monitor pharmacokinetic and safety parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has a previously documented diagnosis of ulcerative colitis (UC) with endoscopy and histology consistent with diagnosis\n* If female, the subject is at least 2 years postmenopausal or is surgically sterile per documentation provided by a third party medical professional or the subject agrees to use 2 highly effective methods of birth control during the study and is not pregnant or lactating\n* Subject is willing and able to comply with the study requirements\n* Subject has a body mass index (BMI) of \\<32 kg/m2\n* Subject has ulcerative colitis requiring treatment with 5-aminosalicylic acid (5-ASA)\n\nExclusion Criteria:\n\n* Subject has undergone previous resective colonic surgery\n* Subject has previously diagnosed Crohn's Disease based on medical history\n* Subject has an extension of disease limited to ulcerative proctitis\n* Subject has active peptic ulcer disease based on medical history\n* Subject is currently being treated with any prescription medication except the following: A stable dose of 5-aminosalicylic acid (5-ASA) for at least 2 weeks, oral contraceptives or hormone replacement therapy (HRT)\n* Subject has a history of human immunodeficiency virus (HIV)\n* Subject has a history of severe allergic or anaphylactic reactions\n* Subject has a history of drug or alcohol abuse"}, 'identificationModule': {'nctId': 'NCT01320332', 'briefTitle': 'A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Telsar Pharma Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative Colitis', 'orgStudyIdInfo': {'id': '3291-CL-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP3291 low dose', 'interventionNames': ['Drug: ASP3291']}, {'type': 'EXPERIMENTAL', 'label': 'ASP3291 high dose', 'interventionNames': ['Drug: ASP3291']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASP3291', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['ASP3291 high dose', 'ASP3291 low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'SNBL Clinical Pharmacology Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Senior Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Telsar Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}