A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.
NCT07032272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-03-30
Summary
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
- DRUG
-
Tablet with oral route of administration
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-23
- Primary Completion
- 2025-10-12
- Completion
- 2025-10-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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