NCT05026996

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

A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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%).

Detailed description

The study consisted of a Screening period of up to 28 days, followed by Baseline evaluations on Day -1. Participants who met the eligibility criteria at Screening were admitted to Baseline evaluations. On Day 1, participants received a single s.c. injection of 80 mg pelacarsen followed by PK sampling up to Day 60 (±3 days). Participants were domiciled for at least 4 overnight stays (Day -1 through Day 4) for PK sample collection up to 72 hours postdose and were to return to the study site on 3 occasions (Days 8, 30 \[±2 days\], and 60 \[±3 days\]) for additional PK sample collection. Study Completion evaluation occurred with the completion of Day 60 (±3 days) assessments. The total study duration for each participant was expected to be up to a maximum of 89 (±3) days, including the Screening period. A post study safety contact took place on Day 112, approximately 16 weeks after dosing.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Pelacarsen	Single subcutaneous injection of pelacarsen

Timeline

• Start date: 2021-11-23
• Primary completion: 2022-10-19
• Completion: 2022-10-19
• First posted: 2021-08-30
• Last updated: 2024-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study