Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 423 · 1 trial · 1 indication
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...
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AMG 423 is an investigational small molecule being developed for the treatment of heart failure. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. A completed Phase 1 study evaluated its pharmacokinetics in healthy subjects and in subjects with various degrees of renal insufficiency.
AMG 423 is being developed by Cytokinetics, Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker symbol CYTK. The company is conducting clinical research on this investigational small molecule for the treatment of heart failure.
AMG 423 is in Phase 1 clinical development. A Phase 1 study, NCT01737866, has been completed. This study evaluated the pharmacokinetics of AMG 423 in healthy subjects and in subjects with various degrees of renal insufficiency. The drug is investigational and not yet approved.
AMG 423 has one completed clinical trial, NCT01737866, titled "Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency." This Phase 1 study enrolled 13 participants in the United States and included healthy volunteers.
No alternative names for AMG 423 have been identified. The drug is known solely by its development code AMG 423 and is being studied by Cytokinetics for heart failure. It is a small molecule in Phase 1 clinical development.