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.

The study comprised of a screening period up to 28 days, one Baseline evaluation on Day -1, a single dose administration of 200 mg of iptacopan followed by PK sampling to 240 hr, and an End-of-Study (EOS) visit (Day 11). All participants had a post study safety follow-up call conducted approximately 30 days after last administration of study drug.

Inclusion Criteria:

Participants eligible for inclusion in this study met the following key criteria:

• Written informed consent was obtained before performing any assessment.
• Male participants and female participants of non-childbearing potential 18 to 75 years of age (inclusive).
• Participants were to weigh at least 55 kg to participate in the study and were to have a body mass index (BMI) within the range of 18 to 35 kg/m2 for healthy participants.

For hepatic impairment participants without overt ascites, the BMI was to be within the range of 18 to 40 kg/m2. For hepatic impairment participants with overt ascites, the BMI was to be within the range of 18 to 45 kg/m2.

• Ability to communicate well with the Investigator, to understand and comply with the requirements of the study.
• Participant was willing to remain in the clinical research unit as required by the protocol

Exclusion Criteria:

Participants meeting any of the following criteria were excluded from this study:

• Use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing, whichever was longer.
• History of hypersensitivity to the investigational compound/compound class or its excipients being used in this study.
• Pregnant or nursing (lactating) women. Pregnancy was defined as the state of a female after conception and until termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
• Known history of, or current clinically significant arrhythmias, history of prolonged QT correction formula (QTcF) interval or QTcF > 450 msec (males) or QTcF > 460 msec (females) at screening in healthy participants and history of prolonged QTcF interval or QTcF > 470 msec (males) or QTcF > 480 msec (females) at screening in participants with hepatic impairment.