38 Participants Needed

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.

NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

Written approval was procured prior to any evaluation.
You possess the capacity to effectively converse with the investigator, comprehend and adhere to the study's demands.
You must be prepared to stay in the clinical research center as specified by the protocol.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Baseline Evaluation

Baseline evaluation conducted on Day -1 before the administration of the study drug

1 day
1 visit (in-person)

Treatment

Single dose administration of 200 mg of iptacopan followed by pharmacokinetic sampling

11 days
Daily visits for PK sampling

Follow-up

Participants are monitored for safety approximately 30 days after the last administration of the study drug

30 days
1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

  • Iptacopan
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Severe hepatic impairment patientsExperimental Treatment1 Intervention
Iptacopan 200 mg single dose
Group II: Moderate hepatic impairment patientsExperimental Treatment1 Intervention
Iptacopan 200 mg single dose
Group III: Mild hepatic impairment patientsExperimental Treatment1 Intervention
Iptacopan 200 mg single dose
Group IV: Healthy participantsExperimental Treatment1 Intervention
Iptacopan 200 mg single dose

Iptacopan is already approved in United States for the following indications:

🇺🇸
Approved in United States as Fabhalta for:
  • Paroxysmal nocturnal hemoglobinuria (PNH)
  • Primary immunoglobulin A nephropathy (IgAN)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

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