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

Part of paid clinical trials in Rialto, California.

Sponsor
Amgen
Study ID
NCT05481411
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.

Key Dates

Start date
Sep 13, 2022
Status verified
Oct 2025
Primary completion
Apr 5, 2023
Completion
May 31, 2023

Study Design

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

Arms

  • Experimental: Single Dose Olpasiran Hepatic Impairment
    Participants will be enrolled in 1 of 3 hepatic impairment groups based on their hepatic impairment status, as determined by Child-Pugh classification. All participants will receive a single dose of olpasiran on Day 1.
  • Experimental: Single Dose Olpasiran Normal Hepatic Function
    Participants with normal hepatic 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 (3)

FacilityCityStateZIPSite coordinators
Inland Empire Clinical Trials, LLCRialtoCalifornia92377-
Orlando Clinical Research CenterOrlandoFlorida32809-
The Texas Liver Institute, Inc.San AntonioTexas78215-

Find similar trials in Rialto, CA

By research site
Inland Empire Clinical Trials, LLC· Rialto, CAOrlando Clinical Research Center· Orlando, FLThe Texas Liver Institute, Inc.· San Antonio, TX

Related Studies