A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function

Part of paid clinical trials in Miami, Florida.

Sponsor
Amgen
Study ID
NCT07428525
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • AMG 133 — DRUG
    Participants will receive AMG 133 SC.

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.

Key Dates

Start date
Mar 14, 2025
Status verified
Mar 2026
Primary completion
Feb 26, 2026
Completion
Feb 26, 2026

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1, AMG 133: Normal Hepatic Function (No Impairment)
    Participants with normal hepatic function will receive a single dose of AMG 133 SC on Day 1.
  • Experimental: Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment)
    Participants with mild hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
  • Experimental: Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment)
    Participants with moderate hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
  • Experimental: Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment)
    Participants with severe hepatic impairment will receive a single dose of AMG 133 SC on Day 1.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of AMG 133 [ Time Frame: Up to Day 120 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology Of Miami, LLCMiamiFlorida33172-
Panax Clinical ResearchMiami LakesFlorida33014-2811-
Orlando Clinical Research CenterOrlandoFlorida32809-
Pinnacle Clinical Research San AntonioSan AntonioTexas78229-4801-
The Texas Liver Institute, Inc.San AntonioTexas78215-2100-

Find similar trials in Miami, FL

By research site
Clinical Pharmacology Of Miami, LLC· Miami, FLPanax Clinical Research· Miami Lakes, FLOrlando Clinical Research Center· Orlando, FLPinnacle Clinical Research San Antonio· San Antonio, TXThe Texas Liver Institute, Inc.· San Antonio, TX

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