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.

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05078580
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Iptacopan — DRUG
    Single oral dose of iptacopan 200 mg oral capsules
  • Iptacopan — DRUG
    Single oral dose of iptacopan 200 mg oral capsules
  • Iptacopan — DRUG
    Single oral dose of Iptacopan 200 mg oral capsules
  • Iptacopan — DRUG
    Single oral dose of Iptacopan 200 mg oral capsules

Study Details

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 Dates

Start date
Nov 10, 2021
Status verified
Jul 2023
Primary completion
Jun 20, 2022
Completion
Jun 20, 2022

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Healthy participants
    Iptacopan 200 mg single dose
  • Experimental: Mild hepatic impairment patients
    Iptacopan 200 mg single dose
  • Experimental: Moderate hepatic impairment patients
    Iptacopan 200 mg single dose
  • Experimental: Severe hepatic impairment patients
    Iptacopan 200 mg single dose

Primary Outcome Measure

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) [ Time Frame: 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteSan AntonioTexas78215-

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Novartis Investigative Site· San Antonio, TX

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