A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment

Part of paid clinical trials in Rialto, California.

Sponsor
Amgen
Study ID
NCT05489614
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Olpasiran — DRUG
    Participants will receive olpasiran by subcutaneous (SC) injection.

Study Details

The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and participants with various degrees of renal impairment.

Key Dates

Start date
Sep 13, 2022
Status verified
Nov 2025
Primary completion
Oct 24, 2023
Completion
Dec 19, 2023

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single Dose Olpasiran Renal Impairment
    Participants will be enrolled in 1 of 5 renal function groups based on their renal impairment status, as determined by estimated glomerular filtration rate (eGFR). All participants will receive a single dose of olpasiran on Day 1.
  • Experimental: Single Dose Olpasiran Normal Renal Function
    Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1.

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) of Olpasiran [ Time Frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Inland Empire Clinical Trials, LLCRialtoCalifornia92377-4697-
CRSCA HC LLC, dba Creekside Post AcuteYucaipaCalifornia92399-
Advanced Pharma CR, LLCMiamiFlorida33147-4040-
Clinical Pharmacology Of Miami, LLCMiamiFlorida33014-
Orlando Clinical Research CenterOrlandoFlorida32809-
Nucleus Network - MinneapolisSaint PaulMinnesota55114-

Find similar trials in Rialto, CA

By research site
Inland Empire Clinical Trials, LLC· Rialto, CACRSCA HC LLC, dba Creekside Post Acute· Yucaipa, CAAdvanced Pharma CR, LLC· Miami, FLClinical Pharmacology Of Miami, LLC· Miami, FLOrlando Clinical Research Center· Orlando, FLNucleus Network - Minneapolis· Saint Paul, MN

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