NCT01929109

A Study of LY2409021 in Participants With Different Levels of Kidney Function

Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to measure how much of the study drug, LY2409021, gets into the blood stream and how long it takes the body to get rid of it when given to participants with different levels of kidney function. There were five study groups. Each participant only enrolled in one group. Participants in groups 1 through 4 were healthy or have mild, moderate, or severe kidney disease. They completed one study period lasting about 29 days. Study group 5 enrolled participants with kidney disease who were on dialysis. They have completed two study periods which together last about 59 days. Screening was required within 21 days prior to the start of the study for all participants.

Conditions

• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	LY2409021	Administered orally

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-08-27
• Last updated: 2018-10-29
• Results posted: 2018-10-29

Locations

2 sites across 2 countries: Germany, United Kingdom