Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

Part of paid clinical trials in Miami, Florida.

Sponsor
AstraZeneca
Study ID
NCT07154901
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Opemalirsen (AZD2373) — DRUG
    Single, subcutaneous injection of AZD2373

Study Details

This study is being conducted to investigate the PK, safety, and tolerability of opemalirsen in participants with renal impairment, compared to participants with normal renal function.

Key Dates

First listed
Sep 4, 2025
Start date
Aug 18, 2025
Status verified
Jun 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group 1
    Healthy participants will receive a single subcutaneous injection of AZD2373.
  • Experimental: Group 2
    Severe renal impairment participants will receive a single subcutaneous injection of AZD2373.
  • Experimental: Group 3
    Moderate renal impairment participants will receive a single subcutaneous injection of AZD2373
  • Experimental: Group 4
    Mild renal impairment participants will receive a single subcutaneous injection of AZD2373

Primary Outcome Measure

AUCinf [ Time Frame: Pre-dose to 3 weeks post dose ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteMiamiFlorida33172-
Research SiteOrlandoFlorida32808-

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