A Phase 1 interventional study of LY2801653 in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-19.
Sponsored by Eli Lilly and Company · Phase 1 and Interventional
The purpose of this study is to evaluate how much of the LY2801653 drug is available in the body when given in 2 different formulations with and without a meal to healthy participants who are not able to have children. In addition, this study will measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study will last about 27 days. Screening is required within 28 days prior to the start of the study.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods.
Drug: LY2801653
Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods.
Drug: LY2801653
Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods.
Drug: LY2801653
Administered orally
Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653
Time frame: Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653
Time frame: Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652
Time frame: Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652
Time frame: Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company