Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01427972 | A Study of LY2623091 in Male and Females With Chronic Kidney Disease | PHASE2 | COMPLETED | 42 | — | — | Sep 1, 2011 | Mar 1, 2013 | Sep 9, 2019 | 4 | Bulgaria, South Africa |
| NCT01237899 | Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance | PHASE1 | COMPLETED | 32 | — | — | Oct 1, 2010 | Jan 1, 2011 | Jun 3, 2019 | 1 | Netherlands |
Proteinuria was the presence of excess serum protein in the urine. Proteinuria was calculated for each participant after each treatment period. Change was calculated as (Day 21 post-treatment value) minus (baseline value).
A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
| Arm | Type | Description |
|---|---|---|
| 0.2 milligrams (mg) LY2623091 | EXPERIMENTAL | 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 |
| 1.5 mg LY2623091 | EXPERIMENTAL | 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 |
| 10 mg LY2623091 | EXPERIMENTAL | 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 |
| 50 mg Eplerenone | ACTIVE_COMPARATOR | 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 |
| 1 mg LY2623091 | EXPERIMENTAL | Daily by mouth for 7 days. |
| 25 mg LY2623091 | EXPERIMENTAL | 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. |
| 0.3 mg LY2623091 | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | Daily by mouth for 7 days. |
| Name | Type | Description |
|---|---|---|
| LY2623091 | DRUG | Administered orally |
| Eplerenone | DRUG | Administered orally |
| Placebo | DRUG | Administered orally. |
Inclusion Criteria: * Men and women of non-childbearing potential as determined by medical history and physical examination 1. Male participants: Non-vasectomized male participants must agree to use 2 medically accepted methods of contraception with all sexual partners during the study and for 9...