A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the Body

Part of paid clinical trials in Lake Forest, California.

Sponsor
Amgen
Study ID
NCT07429045
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • AMG 133 — DRUG
    Participants will receive one dose of AMG 133 as a SC injection.

Study Details

The primary objective of this trial is to evaluate the pharmacokinetics of a single subcutaneous (SC) dose of AMG 133 in participants with various degrees of renal impairment compared to participants with normal renal function.

Key Dates

Start date
Mar 11, 2025
Status verified
Dec 2025
Primary completion
Nov 21, 2025
Completion
Nov 21, 2025

Study Design

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

Arms

  • Experimental: Group 1: Normal renal function
    Participants with an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min will receive a single dose of AMG 133 as a SC injection.
  • Experimental: Group 2: Mild renal impairment
    Participants with an eGFR of 60 to \< 90 mL/min will receive a single dose of AMG 133 as a SC injection.
  • Experimental: Group 3: Moderate renal impairment
    Participants with an eGFR of 30 to \< 60 mL/min will receive a single dose of AMG 133 as a SC injection.
  • Experimental: Group 4: Severe renal impairment and kidney failure not receiving hemodialysis
    Participants with an eGFR of \< 30 mL/min will receive a single dose of AMG 133 as a SC injection.
  • Experimental: Group 5: Kidney failure receiving hemodialysis
    Participants with an eGFR of \< 15 mL/min will receive a single dose of AMG 133 as a SC injection.

Primary Outcome Measure

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

Locations (5)

FacilityCityStateZIPSite coordinators
Orange County Research CenterLake ForestCalifornia92630-
AdvancedPharma CR LLCMiamiFlorida33147-4040-
Floridian Clinical Research, LLCMiami LakesFlorida33016-
Omega Research Group, LLC - OrlandoOrlandoFlorida32806-1133-
Orlando Clinical Research CenterOrlandoFlorida32809-3017-

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By research site
Orange County Research Center· Lake Forest, CAAdvancedPharma CR LLC· Miami, FLFloridian Clinical Research, LLC· Miami Lakes, FLOmega Research Group, LLC - Orlando· Orlando, FLOrlando Clinical Research Center· Orlando, FL

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