Conditions: Chronic Kidney Disease
Keywords: Kidney Renal
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: yes

Brief summary:
The purpose of this study is to investigate the safety and tolerability of LY2623091 after multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of 16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind for LY2623091 and placebo (negative control), and open label for eplerenone (positive control).

Detailed description:

Arms:
arm 1: Daily by mouth for 7 days. arm 2: Daily by mouth for 7 days. arm 3: The anticipated dose of LY2623091 was revised down from the original proposed dose level of 100 mg based on safety and tolerability data. The 25 mg LY2623091 was administered daily by mouth for 7 days. arm 4: The anticipated dose of LY2623091 was revised down from the original proposed dose level of up to 200 mg. The 0.3 mg LY2623091 was determined based on an interim analysis after the third dose level and was administered daily by mouth for 7 days. arm 5: Daily by mouth for 7 days. arm 6: Daily by mouth for 7 days.

Interventions: intervention 1: LY2623091 intervention 2: Placebo intervention 3: Eplerenone
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered orally. intervention 3: Administered orally.

Protocol document: