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.
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tested a medication called iptacopan to see how it behaves in people with various levels of liver function. They wanted to understand how the drug is absorbed, distributed, and eliminated from the body.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who have used other investigational drugs recently.
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Evaluation
Baseline evaluation conducted on Day -1 before the administration of the study drug
Treatment
Single dose administration of 200 mg of iptacopan followed by pharmacokinetic sampling
Follow-up
Participants are monitored for safety approximately 30 days after the last administration of the study drug
What Are the Treatments Tested in This Trial?
Interventions
- Iptacopan
Iptacopan is already approved in United States for the following indications:
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Primary immunoglobulin A nephropathy (IgAN)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD