Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05026996
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pelacarsen — DRUG
    Single subcutaneous injection of pelacarsen

Study Details

This was a Phase I, open-label, single-dose, parallel-group study in participants with mild hepatic impairment (HI) and healthy matched control participants with normal hepatic function designed to evaluate the PK of pelacarsen following a single 80 mg s.c. dose. Participants were matched by gender, age (±10 years), and body weight (±15%).

Key Dates

Start date
Nov 23, 2021
Status verified
Oct 2024
Primary completion
Oct 19, 2022
Completion
Oct 19, 2022

Study Design

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

Arms

  • Experimental: Mild hepatic impairment patients
    Participants with mild hepatic impairment
  • Experimental: Healthy participants
    Matched healthy participants with normal hepatic function

Primary Outcome Measure

Pharmacokinetic parameters of pelacarsen: Cmax [ Time Frame: Day 1 (0 hour (pre-dose) 0.5 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour), Day 2, Day 3, Day 4, Day 8, Day 30 and Day 60 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteSan AntonioTexas78215-

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By research site
Novartis Investigative Site· San Antonio, TX

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