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.

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (few time pints), day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 and day 11

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Liver disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (few time pints), day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 and day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (few time pints), day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 and day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (few time pints), day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 and day 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharmacokinetic parameters of iptacopan: AUClast The AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time × volume-1)

Pharmacokinetic parameters of iptacopan: Cmax The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1)

Pharmacokinetics parameters of iptacopan: AUCinf The AUC from time zero to infinity (mass × time × volume-1)

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