Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-28 @ 5:47 AM
Study NCT ID:
NCT01746004
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2012-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY2157299 Monohydrate in Healthy Volunteers
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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-14', 'studyFirstSubmitDate': '2012-12-06', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered', 'timeFrame': 'Pre-dose through Day 15'}], 'secondaryOutcomes': [{'measure': 'Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)', 'timeFrame': 'Pre-dose through Day 14'}, {'measure': 'Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)', 'timeFrame': 'Pre-dose through Day 14'}, {'measure': 'Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Area Under the Concentration-Time Curve from Time Zero to the Last Timepoint with a Measurable Concentration (AUC 0 to tlast)', 'timeFrame': 'Pre-dose through Day 14'}, {'measure': 'Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces', 'timeFrame': 'Pre-dose through Day 14'}, {'measure': 'Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma', 'timeFrame': 'Pre-dose through Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants. The study will determine how the body eliminates the radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal females, or sterile males. This study is approximately 8 to 15 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy surgically sterile females, postmenopausal females, or sterile males\n* Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\\^2)\n* Have venous access sufficient to allow for blood sampling\n\nExclusion Criteria:\n\n* Have known allergies to LY2157299, related compounds or any components of the formulation\n* Have an abnormal blood pressure as determined by the investigator\n* Have participated in a \\[\\^14C\\]-study within the last 6 months prior to admission for this study'}, 'identificationModule': {'nctId': 'NCT01746004', 'briefTitle': 'A Study of LY2157299 Monohydrate in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Disposition of [14C]-LY2157299 Monohydrate Following Oral Administration in Healthy Subjects', 'orgStudyIdInfo': {'id': '14671'}, 'secondaryIdInfos': [{'id': 'H9H-MC-JBAM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[^14C]-LY2157299', 'description': 'Single 150 mg oral dose of LY2157299 monohydrate containing 100 micro curies of \\[\\^14C\\] labeled drug', 'interventionNames': ['Drug: [^14C]-LY2157299']}], 'interventions': [{'name': '[^14C]-LY2157299', 'type': 'DRUG', 'description': '\\[\\^14C\\]-LY2157299 monohydrate administered as oral solution', 'armGroupLabels': ['[^14C]-LY2157299']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}