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

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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

NCT07032272•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•All participants (Group 1 \& 2)
•Male and non-childbearing potential female participants 18 to 75 years of age, inclusive, at Screening.
•Must be a non-smoker or a light smoker who smokes no more than 10 cigarettes (or equivalent, including use of nicotine products) per day, at Screening. Smokers must agree to smoke no more than 5 cigarettes (or equivalent) per day from check-in until after Study Completion evaluations.
•Participants with severe RI (Group 1)
•Must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) within the range of 18.0 to 35.0 kg/m2, inclusive, at Screening.
•Seated vital signs must be within the following ranges at Screening and Baseline:
•1. body temperature, 35.0 to 37.5°C, inclusive.
•2. systolic blood pressure, 90 to 159 mmHg, inclusive.
•3. diastolic blood pressure, 60 to 99 mmHg, inclusive.
•4. pulse rate, 50 to 99 bpm, inclusive.
+7 more criteria

Exclusion Criteria

•All participants (Group 1 \& 2)
•Use of other investigational drugs within 5 half-lives or 30 days prior to first dosing of study treatment, whichever is longer, as far as known.
•History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
•Use of prescription drugs, OTC medications, or herbal supplements (within the last 2 weeks prior to first dosing, or use of cannabis/marijuana, within the last 4 weeks prior to initial dosing.
•Participants not willing to abstain from food and beverages known to inhibit or induce CYP3A4 from 7 days prior to first dosing and until their respective EoS visit.
•History or presence of malignancy of any organ system (other than treated localized basal cell or squamous cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years of Screening, regardless of whether there is evidence of local recurrence or metastases.
•History or presence of any ongoing, chronic or recurrent infectious disease (including tuberculosis, atypical mycobacterioses, listeriosis, aspergillosis).
•Participants with a history of bone marrow failure or cytopenia will be excluded from the study.
•Is on immunosuppressant therapy or immunomodulators therapy less than or equal to 4 weeks prior to first dosing.
•Any single parameter of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) or alkaline phosphatase (ALP) exceeding 1.2 x upper limit of normal (ULN) or greater than or equal to 1.5 x ULN total bilirubin (TBL) OR any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or TBL.
+8 more criteria

Locations (4)

Clinical Pharmacology of Miami LLC

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Genesis Clinical Research

Tampa, Florida, United States

Key Dates

Start Date

July 23, 2025

Primary Completion Date

October 12, 2025

Completion Date

October 14, 2025

Last Updated

January 30, 2026

Enrollment

ACTUAL participants

Conditions

Autoimmune and Chronic Inflammatory Diseases

Interventions

remibrutinib

DRUG