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.
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
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.
Key facts
- Study ID
- NCT05078580
- Run by
- Novartis Pharmaceuticals
- People needed
- 38
- Starts
- 2021-11-10
- Expected to finish
- 2022-06-20
- Last updated by the study team
- 2023-07-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Novartis Investigative Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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