drugset / Trial / 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.

NCT05078580

Phase 1 Completed 38 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupSingle-blindOther

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.

Timeline

Start
2021-11-10
Primary completion
2022-06-20
Completion
2022-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Iptacopan Small molecule 200 mg Oral

Indications

No indication recorded.