drugset / Trial / NCT05753592

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

NCT05753592

Phase 1 Completed 38 enrolled Novartis Pharmaceuticals
Non-randomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2022-10-31
Primary completion
2023-12-14
Completion
2023-12-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Remibrutinib Small molecule 25 mg Oral

Indications

No indication recorded.