Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT01818232
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2013-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve (AUC)', 'timeFrame': 'Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Number of subjects experiencing an adverse event', 'timeFrame': 'Day 1 through discharge'}, {'measure': 'Urinary recovery of radioactivity', 'timeFrame': 'predose through 24 hours'}, {'measure': 'Fecal recovery of radioactivity', 'timeFrame': 'predose through 24 hours'}, {'measure': 'Whole blood and plasma concentration of total radioactivity', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This phase 1 study is to evaluate the pharmacokinetics (PK), metabolism, routes and extent of elimination of a single oral dose of 400 mg \\[14C\\]LX4211 to healthy male subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 to ≤55 years of age\n* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm\n* Body mass index (BMI) ≥18 and ≤35 kg/sq m\n* Historically able to produce a minimum of 1 bowel movement per day\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Female\n* Receipt of any investigational drug within 30 days prior to Dosing, or investigational protein or antibody-based therapeutic agents within 3 months prior to Screening\n* Prior exposure to LX4211\n* Use any tobacco product within 2 months prior to Screening and while participating in the study (Day -1 through Discharge)\n* History of bariatric surgery or any other GI surgery that may induce malabsorption\n* History of any major surgery within 6 months prior to Screening\n* History of renal or hepatic disease, or significantly abnormal kidney or liver function tests at Screening\n* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, hematological, or GI abnormality\n* History of any active infection within 14 days prior to Dosing\n* History of alcohol or substance abuse within 2 years prior to Dosing\n* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C\n* Donation or loss of \\>400 mL of blood or blood product within 3 months of Dosing\n* Positive urine glucose at Screening\n* Positive urine screen for drugs of abuse at Screening or Day -1\n* Positive breath test for alcohol at Screening or Day -1\n* Participation in \\>1 other radiolabeled investigational study drug trial within 12 months prior to Day -1\n* Exposure to significant radiation within 12 months prior to Day -1'}, 'identificationModule': {'nctId': 'NCT01818232', 'acronym': 'AME', 'briefTitle': 'Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Open-label, Nonrandomized, Single Dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-LX4211, Following Oral Administration, in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'LX4211.1-108-NRM'}, 'secondaryIdInfos': [{'id': 'LX4211.108'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]-LX4211', 'description': '400 mg LX4211 administered orally', 'interventionNames': ['Drug: [14C]-LX4211']}], 'interventions': [{'name': '[14C]-LX4211', 'type': 'DRUG', 'armGroupLabels': ['[14C]-LX4211']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ikenna Ogbaa, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lexicon Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}