A Study of [¹⁴C]-LY3202626 in Healthy Male Participants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02555449|
Recruitment Status : Completed
First Posted : September 21, 2015
Last Update Posted : December 16, 2015
The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon [¹⁴C] 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.
Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.
This study is for research purposes only and is not intended to treat any medical condition.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: [¹⁴C]-LY3202626||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Single oral dose of LY3202626 containing 100 micro curies of radioactivity
Administered as solution by mouth
- Fecal Excretion of LY3202626 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Pre-dose up to 22 days post-dose ]
- Urinary Excretion of LY3202626 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Pre-dose up to 22 days post-dose ]
- Plasma Pharmacokinetics of LY3202626 and Radioactivity Maximum Observed Concentration (Cmax) [ Time Frame: Pre-dose up to 22 days post-dose ]
- Plasma Pharmacokinetics of LY3202626 and radioactivity area under the concentration-time curve from time zero to infinity (AUC 0 to infinity) [ Time Frame: Pre-dose up to 22 days post-dose ]
- Plasma pharmacokinetics of LY3202626 and radioactivity area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC 0 to tlast) [ Time Frame: Pre-dose up to 22 days post-dose ]
- Total number of metabolites representing at least 10% of the total radioactivity in plasma, urine and/or feces [ Time Frame: Pre-dose up to 22 days post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555449
|United States, Wisconsin|
|Covance Clinical Research Unit Inc.|
|Madison, Wisconsin, United States, 53704|
|Study Director:||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)||Eli Lilly and Company|