Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00449202
Status:
UNKNOWN
Last Update Posted:
2007-03-20
First Post:
2007-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108709', 'term': 'oleoyl-estrone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2007-03', 'lastUpdateSubmitDate': '2007-03-16', 'studyFirstSubmitDate': '2007-03-16', 'studyFirstSubmitQcDate': '2007-03-16', 'lastUpdatePostDateStruct': {'date': '2007-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'To evaluate the preliminary efficacy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be a male or female between the ages of 18 and 65 years, inclusive\n* Female subjects must be either surgically sterile or at least 2 years postmenopausal\n* Have a BMI of 27 - 38.9, inclusive\n* Have a stable weight for the past 30 days per subject report\n* Be otherwise healthy and have an acceptable medical history\n* Have negative urinalysis test results for drugs of abuse and alcohol\n* Have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions\n* Exhibit stable behavior patterns with regard to smoking and exercise\n* Subject who has at least one factor of the metabolic syndrome\n\nExclusion Criteria:\n\n* Be pregnant or nursing\n* Have taken exclusionary medication in the past 30 days\n* Have any clinically significant abnormal laboratory test as determined by the investigator\n* Have a clinically significant illness during the 30 days before enrollment\n* Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV\n* Have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer\n* Have a previous diagnosis of diabetes\n* Be otherwise unsuitable for the study, in the opinion of the investigator\n* Have an allergy to safflower seeds or its byproducts (e.g., safflower oil)\n* Have any postmenopausal bleeding within the last 6 months\n* Have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days\n* Currently working night shifts\n* Have a history of known multiple miscarriages'}, 'identificationModule': {'nctId': 'NCT00449202', 'briefTitle': 'Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Manhattan Pharmaceuticals'}, 'officialTitle': 'A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Two 14 Day Cycles of Oral Doses of Oleoyl-Estrone (MP-101) in Obese Adult Subjects', 'orgStudyIdInfo': {'id': 'MAN-OE-OS-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'oleoyl-estrone (MP 101)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Swiss Pharma Contract', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manhattan Pharmaceuticals', 'class': 'INDUSTRY'}}}}