Conditions: Chronic Kidney Disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 42
Healthy volunteers: no

Brief summary:
The purpose of this trial is to investigate the safety and efficacy of LY2623091 in males and females with chronic kidney disease.

Detailed description:
This trial consists of 4 treatment arms: 3 LY2623091 dose levels and eplerenone. Each participant will participate in 2 treatment periods, with a minimum wash-out period of 28 days between dosing in the 2 treatment periods. Dosing days will be numbered 1-21 in each of the 2 treatment periods. Participants will receive different treatments in periods 1 and 2. Participants will be housed as inpatients during the days of the controlled diet administration and the oral potassium challenge and until at least 24 hours after its completion (Days -3 to 1; Days 19 to 22, in each treatment period). Otherwise the study will be done on an outpatient basis, with participants returning to the clinic for evaluations during each treatment period (Days 3 or 4, 7, and 14).

Arms:
arm 1: Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods arm 2: Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods arm 3: Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods arm 4: Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods

Interventions: intervention 1: LY2623091 intervention 2: Eplerenone
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol document: