Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Study Details
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
Protocol Summary
Subject incidence of treatment-emergent adverse events
Timeframe: up to 365 days
Changes in blood pressure
Timeframe: Up to 365 days
Changes in heart rate
Timeframe: Up to 365 days
Changes in respiratory rate
Timeframe: Up to 365 days
Changes in temperature
Timeframe: Up to 365 days
Changes in QRS interval
Timeframe: Up to 365 days
Changes in PR interval
Timeframe: Up to 365 days
Changes in QT interval
Timeframe: Up to 365 days
Changes in RR interval
Timeframe: Up to 365 days
Changes in red blood cells
Timeframe: Up to 365 days
Changes in platelets
Timeframe: Up to 365 days
Changes in white blood cells
Timeframe: Up to 365 days
Changes in prothrombin time (PT)
Timeframe: Up to 365 days
Changes in international normalized ratio (INR)
Timeframe: Up to 365 days
Changes in activated partial thromboplastin time (aPTT)
Timeframe: Up to 365 days
Changes in Thrombin time (TT)
Timeframe: Up to 365 days
Changes in aspartate aminotransferase (AST) levels (units: U/L)
Timeframe: Up to 365 days
Changes in alanine aminotransferase (ALT) levels (units: U/L)
Timeframe: Up to 365 days
Changes in total bilirubin levels (units: μmol/L)
Timeframe: Up to 365 days
Changes in direct bilirubin levels (units: μmol/L)
Timeframe: Up to 365 days
Changes in alkaline phosphatase levels (units: U/L)
Timeframe: Up to 365 days
Changes in total protein levels (units: g/L)
Timeframe: Up to 365 days
Changes in albumin levels (units: g/L)
Timeframe: Up to 365 days
Pharmacokinetics parameter of maximum observed concentration (Cmax)
Timeframe: up to 365 days
Pharmacokinetics parameter of time of maximum observed concentration (tmax)
Timeframe: up to 365 days
Pharmacokinetics parameter of area under the concentration time curve (AUC)
Timeframe: up to 365 days
Change in plasma Lp(a) over time
Timeframe: Up to 365 days
Percent change in plasma Lp(a) over time
Timeframe: Up to 365 days