Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 1:07 AM
Study NCT ID:
NCT01164904
Status:
TERMINATED
Last Update Posted:
2013-07-25
First Post:
2010-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591337', 'term': 'abrilumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)', 'timeFrame': 'Through study completion'}], 'secondaryOutcomes': [{'measure': 'To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181', 'timeFrame': 'Through study completion'}, {'measure': 'To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations', 'timeFrame': 'Through study completion'}]}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'Amgen'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Healthy Volunteers\n\n* Healthy male or female subjects of non-reproductive potential between 18 to 45 year-of -age\n* Body Mass Index (BMI) between 18 and 34 kg/m2\n* Normal physical and neurological examination, clinical laboratory values and ECG\n* Additional inclusion criteria apply\n\nInclusion Criteria: Subjects with Mild to Moderate Ulcerative Colitis\n\n* Male or female subjects between 18 to 55 year-of -age\n* Body Mass Index (BMI) between 18 and 34 kg/m2\n* Diagnosis of Ulcerative Colitis for at least 2 months\n* Active, mild to moderate disease as defined by an Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 9 (inclusive), with a minimum sigmoidoscopy score of 1\n* Additional inclusion criteria apply\n\nExclusion criteria: Healthy Volunteers\n\n* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion\n* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years\n* Recent or on-going infection(s)\n* Underlying condition(s) that predisposes the subject to infections\n* Additional exclusion criteria apply\n\nExclusion criteria: Subjects with Mild to Moderate Ulcerative Colitis\n\n* Disease limited to the rectum, i.e. within 20 cm of the anal verge\n* Any prior gastrointestinal surgery\n* Evidence of severe disease (as evidenced by an Hb concentration \\<11g/dL; toxic megacolon, or an UCDAI scoreā„10)\n* Immunosuppressive therapy with either azathioprine, methotrexate, or mercaptopurine, within the past 3 months\n* Prior exposure to a biologic agent or cyclosporine A\n* Use of antibiotics within the past 2 weeks of screening and during screening period\n* Use of topical (e.g. suppository or enema) mesalamine or steroids within two weeks prior to day 1\n* Additional exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT01164904', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis', 'orgStudyIdInfo': {'id': '20090107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Ten escalating dose levels of AMG 181 administered as a single dose SC or IV in healthy volunteers and SC in subjects with mild-to-moderate ulcerative colitis.', 'interventionNames': ['Drug: Amg 181']}], 'interventions': [{'name': 'Amg 181', 'type': 'DRUG', 'description': 'Ten escalating dose levels of AMG 181 administered as single dose SC or IV, in healthy volunteers and SC subjects with mild-to-moderate ulcerative colitis.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '55446', 'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3004', 'city': 'Prahran', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.85114, 'lon': 144.99318}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Research Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Research Site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}