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

Phase 1 Completed 17 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelOther

Summary

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%).

Timeline

Start: 2021-11-23
Primary completion: 2022-10-19
Completion: 2022-10-19

Publications

Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pelacarsen	Antisense oligonucleotide	80 mg	Subcutaneous

Indications

No indication recorded.