NCT07032272

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

A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Safety of Remibrutinib (LOU064) in Participants With Severe Renal Impairment Compared to Matched Healthy Participants With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.

Detailed description

This is a Phase 1, open-label, non-randomized study to evaluate the PK after five administrations of remibrutinib in participants with severe RI compared to matched healthy control participants with normal renal function.The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.

Conditions

• Autoimmune and Chronic Inflammatory Diseases

Interventions

Type	Name	Description
DRUG	remibrutinib	Tablet with oral route of administration

Timeline

• Start date: 2025-07-23
• Primary completion: 2025-10-12
• Completion: 2025-10-14
• First posted: 2025-06-22
• Last updated: 2026-03-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study