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.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Novartis Pharmaceuticals
No Placebo Group
Breakthrough Therapy
Approved in 1 Jurisdiction
Trial Summary
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.
Research Team
NP
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
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.
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Treatment Details
Interventions
- Iptacopan (Complement Inhibitor)
Participant Groups
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
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
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD