Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function
Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function
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.
Inclusion Criteria:
Inclusion Criteria for ALL Participants
Additional Inclusion Criteria for Control (Healthy) Participants
- Control participants must have normal renal function, assessed by mean estimated creatinine clearance (CLcr) greater than or equal to (≥)90 milliliter per minute (mL/min) at screening and day before dosing
Additional Inclusion Criteria for Participants with Mild-to-Severe Renal Impairment or End Stage Renal Disease (ESRD)
- Males or females with stable mild-to-severe renal impairment, assessed by estimated CLcr, or with ESRD requiring hemodialysis (or hemodiafiltration) for at least 3 months
Additional Inclusion Criteria for Participants with Type 2 Diabetes Mellitus (T2DM)
- Participants with T2DM that are being treated with diet or exercise alone or receive treatment with insulin
Exclusion Criteria:
Exclusion Criteria for ALL Participants
Additional Exclusion Criteria for Participants with Mild, Moderate or Severe Renal Impairment or ESRD:
Additional Exclusion Criteria for Participants with T2DM:
Munich, 81241, Germany