Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT00427258
Status:
WITHDRAWN
Last Update Posted:
2019-11-29
First Post:
2007-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating MOA-728 Administered in Healthy Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-01'}, 'statusVerifiedDate': '2019-11', 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2007-01-25', 'studyFirstSubmitQcDate': '2007-01-26', 'lastUpdatePostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of drug using radioactive study drug.'}]}, 'conditionsModule': {'keywords': ['healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Absorption, distribution, metabolism, and excretion (ADME) study with 14C in healthy young men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men aged 18 to 50 years inclusive at screening.\n* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = weight (kg)/\\[height (m)\\]2\n* Healthy as determined by the investigator on the basis of screening evaluations.\n* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay."}, 'identificationModule': {'nctId': 'NCT00427258', 'briefTitle': 'Study Evaluating MOA-728 Administered in Healthy Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]MOA-728 in Healthy Men', 'orgStudyIdInfo': {'id': '3200A3-1106'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MOA-728', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'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'}}}}