A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05753592
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This was a Phase 1, open-label study to evaluate the PK, safety, and tolerability after administration of multiple doses of remibrutinib in participants with mild, moderate, or severe hepatic impairment (HI) compared to pooled matched healthy control participants with normal hepatic function.

Key Dates

Start date
Oct 31, 2022
Status verified
May 2025
Primary completion
Dec 14, 2023
Completion
Dec 17, 2023

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1; LOU064 (Remibrutinib)
    Mild and Moderate HI participants and matching healthy participants
  • Experimental: Part 2; LOU064 (Remibrutinib)
    Severe HI participants and matching healthy participants

Primary Outcome Measure

Cmax,ss [ Time Frame: 72 hours ]

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