Study Complete
Sponsor ID
20240024
A Study to Evaluate AMG 133 in Participants with Varying Degrees of Hepatic Impairment or Normal Hepatic Function
Study Details
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.
Protocol Summary
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Timeframe: Up to Day 120
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133
Timeframe: Up to Day 120
AUC from Time Zero to Infinity (AUCinf) of AMG 133
Timeframe: Up to Day 120
Secondary Outcome Measures
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to Day 120
Number of Participants Who Experience Serious Adverse Events (SAEs)
Timeframe: Up to Day 120
Number of Participants Who Develop Anti-AMG 133 Antibodies
Timeframe: Up to Day 120
Locations
Location
The Texas Liver Institute, Inc.
San Antonio,, TX, United States, 78215-2100
Status
Recruiting
Location
Clinical Pharmacology Of Miami, LLC
Miami, FL, United States, 33172
Status
Completed
Location
Panax Clinical Research
Miami Lakes, FL, United States, 33014-2811
Status
Completed
Location
Pinnacle Clinical Research San Antonio
San Antonio, TX, United States, 78229-4801
Status
Completed
Location
Orlando Clinical Research Center
Orlando, FL, United States, 32809
Status
Completed