A Study of LY2784544 in Healthy Male Subjects
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ClinicalTrials.gov Identifier: NCT01577355 |
Recruitment Status
:
Completed
First Posted
: April 13, 2012
Last Update Posted
: July 3, 2012
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
Tracking Information | ||||
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First Submitted Date ICMJE | April 11, 2012 | |||
First Posted Date ICMJE | April 13, 2012 | |||
Last Update Posted Date | July 3, 2012 | |||
Study Start Date ICMJE | April 2012 | |||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Urinary and fecal excretion of LY2784544 radioactivity over time expressed as a percentage of the total radioactive dose administered [ Time Frame: Predose up to 14 days post dose ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01577355 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of LY2784544 in Healthy Male Subjects | |||
Official Title ICMJE | Disposition of [14C]-LY2784544 Following Oral Administration in Healthy Male Subjects | |||
Brief Summary | This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the absorption, distribution, metabolism and excretion of LY2784544. This study is for research purposes only and is not intended to treat any medical condition. | |||
Detailed Description | This study is approximately 10 days long, (minimum 5 days, maximum 15 days) not including screening or follow up. Screening is required within 28 days prior to the first dose of study drug and follow up is required at least 7 days after discharge from the clinical research unit. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Healthy Male Volunteers | |||
Intervention ICMJE | Radiation: Drug
Single 30 mg oral dose containing 100 micro curies of LY2784544 |
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Study Arms | Experimental: [C14]-LY2784544
Single 30 mg oral dose containing 100 micro curies of LY2784544
Intervention: Radiation: Drug |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
8 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | June 2012 | |||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01577355 | |||
Other Study ID Numbers ICMJE | 14484 I3X-MC-JHTD ( Other Identifier: Eli Lilly and Company ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Eli Lilly and Company | |||
Study Sponsor ICMJE | Eli Lilly and Company | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Eli Lilly and Company | |||
Verification Date | July 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |