A Study of LY3031207 in Healthy Subjects
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01449630
First received: October 5, 2011
Last updated: April 13, 2012
Last verified: April 2012
Tracking Information | |||||
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First Received Date ICMJE | October 5, 2011 | ||||
Last Updated Date | April 13, 2012 | ||||
Start Date ICMJE | October 2011 | ||||
Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants with one or more drug related Adverse Events (AEs) or any Serious AEs [ Time Frame: Baseline to study completion (estimate 4 months) ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01449630 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 | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of LY3031207 in Healthy Subjects | ||||
Official Title ICMJE | A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects | ||||
Brief Summary | This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to look at safety, how well the study drug is tolerated, and how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Subjects will participate in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
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Condition ICMJE | Healthy Volunteers | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* 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 | 42 | ||||
Completion Date | April 2012 | ||||
Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01449630 | ||||
Other Study ID Numbers ICMJE | 14283, I5W-EW-LBCA | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Eli Lilly and Company | ||||
Study Sponsor ICMJE | Eli Lilly and Company | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Eli Lilly and Company | ||||
Verification Date | April 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |