A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07032272
- Phase
- PHASE1
- Status
- Completed
Conditions
- Autoimmune and Chronic Inflammatory Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- remibrutinib — DRUGTablet with oral route of administration
Study Details
The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.
Key Dates
- Start date
- Jul 23, 2025
- Status verified
- Mar 2026
- Primary completion
- Oct 12, 2025
- Completion
- Oct 14, 2025
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Participants with severe renal impairmentParticipants with severe renal impairment will receive remibrutinib
- Experimental: Healthy participantsMatched healthy participants will receive remibrutinib
Primary Outcome Measure
Cmax, ss of remibrutinib in blood [ Time Frame: Up to 72 hours postdose ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Pharmacology of Miami LLC | Miami | Florida | 33014-3616 | - |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | - |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | - |
| Genesis Clinical Research | Tampa | Florida | 33614 | - |