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Antisense Oligonucleotide

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

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group

Summary

This trial tests how a single injection of pelacarsen behaves in people with mild liver problems. Researchers want to see how the drug is absorbed, distributed, and eliminated from the body.

Eligible Conditions
  • Liver disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetic parameters of pelacarsen: AUCinf
Pharmacokinetic parameters of pelacarsen: AUClast
Pharmacokinetic parameters of pelacarsen: Cmax

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Mild hepatic impairment patientsExperimental Treatment1 Intervention
Participants with mild hepatic impairment
Group II: Healthy participantsExperimental Treatment1 Intervention
Matched healthy participants with normal hepatic function
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pelacarsen
2018
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,868 Total Patients Enrolled
~4 spots leftby Dec 2025
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