Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-27 @ 9:54 AM
Study NCT ID:
NCT00311350
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2006-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2006-08'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2006-04-03', 'studyFirstSubmitQcDate': '2006-04-03', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety'}]}, 'conditionsModule': {'keywords': ['Safety', 'Health', 'Pharmacokinetics', 'ileus'], 'conditions': ['Postoperative Complications', 'Constipation']}, 'descriptionModule': {'briefSummary': 'This is the first multiple-dose experience in humans with MOA-728 in an oral formulation. This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK) of MOA-728 following administration of ascending multiple oral doses to healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women'}, 'identificationModule': {'nctId': 'NCT00311350', 'briefTitle': 'Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of MOA-728 Administered Orally to Healthy Subjects', 'orgStudyIdInfo': {'id': '3200A3-100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MOA-728', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19148', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jeff Cohn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch Health Americas, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jeff Cohn', 'oldOrganization': 'Salix Pharmaceuticals'}}}}