NCT05078580

Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.

A Phase 1, Single Dose, Open-label Study to Investigate the Pharmacokinetics and Safety of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.

Detailed description

The study comprised of a screening period up to 28 days, one Baseline evaluation on Day -1, a single dose administration of 200 mg of iptacopan followed by PK sampling to 240 hr, and an End-of-Study (EOS) visit (Day 11). All participants had a post study safety follow-up call conducted approximately 30 days after last administration of study drug.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Iptacopan	Single oral dose of iptacopan 200 mg oral capsules
DRUG	Iptacopan	Single oral dose of iptacopan 200 mg oral capsules
DRUG	Iptacopan	Single oral dose of Iptacopan 200 mg oral capsules
DRUG	Iptacopan	Single oral dose of Iptacopan 200 mg oral capsules

Timeline

• Start date: 2021-11-10
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2021-10-14
• Last updated: 2023-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study