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.

NCT05078580 | Completed Phase 1 FDA Drug

• 1 other identifier: CLNP023A2105
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatic Impairment

Keywords

LNP023; iptacopan; hepatic impairment; single-dose

Outcome Measures

Primary Outcomes (4)

• 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)

  To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).

  Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11

• Pharmacokinetics parameters of iptacopan: Tmax The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)

  To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).

  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

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

  To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).

  Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11

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

  to assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).

  Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11

Study Arms (4)

Healthy participants

EXPERIMENTAL

Iptacopan 200 mg single dose

Drug: Iptacopan

Mild hepatic impairment patients

EXPERIMENTAL

Iptacopan 200 mg single dose

Drug: Iptacopan

Moderate hepatic impairment patients

EXPERIMENTAL

Iptacopan 200 mg single dose

Drug: Iptacopan

Severe hepatic impairment patients

EXPERIMENTAL

Iptacopan 200 mg single dose

Drug: Iptacopan

Interventions

Iptacopan DRUG

Single oral dose of iptacopan 200 mg oral capsules

Also known as: LNP023

Healthy participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

San Antonio, Texas, 78215, United States

Location

Related Links

• A Plain Language Trial Summary is available on novctrd.com.

MeSH Terms

Interventions

iptacopan

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 14, 2021
• Study Start: November 10, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)