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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01737866 | Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency | PHASE1 | COMPLETED | 13 | — | — | Nov 1, 2012 | May 1, 2013 | Jul 30, 2021 | 1 | United States |
Part A and Part B: Total AMG 423 pharmacokinetic parameters including area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable sample (AUC0-t) and maximum observed plasma concentration after dosing (Cmax).
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | End Stage Renal Diseas (ESRD) requiring hemodialysis |
| Group 2 | EXPERIMENTAL | Normal renal function (eGFR \>or = 80mL/min/1.73m\^2) |
| Group 3 | EXPERIMENTAL | Mild decrease in GFR (eGFR 60-79 mL/min/1.73m\^2) |
| Group 4 | EXPERIMENTAL | Moderate decrease in GFR (eGFR 30-59 mL/min/1.73m\^2) |
| Group 5 | EXPERIMENTAL | Severe decrease in GFR (eGFR 15-29 mL/min/1.73m\^2) |
| Group 6 | EXPERIMENTAL | Normal renal function (eGFR \>or = 80mL/min/1.73m\^2) |
| Name | Type | Description |
|---|---|---|
| AMG 423 | DRUG | omecamtiv mecarbil |
Inclusion Criteria: * Men or women ≥18 years of age * Laboratory test values (clinical chemistry and hematology)within normal limits, (other than test values out of the normal range for subjects with CKD \[groups 1 and 3 through 5\]), or clinically acceptable to the investigator and sponsor at scre...