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

NCT07032272 | Completed Phase 1 FDA Drug

• 1 other identifier: CLOU064A2105
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Remibrutinib (LOU064); Renal impairment; PK; Safety; Tolerability

Outcome Measures

Primary Outcomes (4)

• Cmax, ss of remibrutinib in blood

  The maximum (peak) observed concentration following multiple-dose administration

  Up to 72 hours postdose

• AUCtau,ss of remibrutinib in blood

  The area under the curve (AUC) from time zero to the end of the dosing interval (tau) following multiple-dose administration

  Up to 72 hours postdose

• Ae0-12h,ss of remibrutinib in urine

  Amount of unchanged drug excreted in the urine collection interval from time zero to 12 hours following multiple-dose administration

  Up to 12 hours postdose

• CLr,ss of remibrutinib in urine

  Renal clearance following multiple-dose administration

  Up to 12 hours postdose

Secondary Outcomes (9)

• Number of participants with adverse events and serious adverse events

  From Day 1 to end of study (up to 30 days after last administration of study treatment)

• Plasma protein binding of remibrutinib (unbound fraction)

  1 hour postdose

• Cmax,ss,u of remibrutinib in plasma

  Up to 72 hours post dose

• AUCtau,ss,u of remibrutinib in plasma

  Up to 72 hours post dose

• AUClast,ss,u of remibrutinib in plasma

  Up to 72 hours post dose

Study Arms (2)

Participants with severe renal impairment

EXPERIMENTAL

Participants with severe renal impairment will receive remibrutinib

Drug: remibrutinib

Healthy participants

EXPERIMENTAL

Matched healthy participants will receive remibrutinib

Drug: remibrutinib

Interventions

remibrutinib DRUG

Tablet with oral route of administration

Healthy participants; Participants with severe renal impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• body temperature, 35.0 to 37.5°C, inclusive.
• systolic blood pressure, 90 to 159 mmHg, inclusive.
• diastolic blood pressure, 60 to 99 mmHg, inclusive.
• pulse rate, 50 to 99 bpm, inclusive.
• Have impaired renal function as determined by eGFR using the CKD-EPI Creatinine - Cystatin C equation (2021), in the following group at Screening: severe RI; eGFR \<30 mL/min, not requiring dialysis.
• Have stable renal function with no clinically significant change in renal status prior to first dosing of study treatment as determined by the Investigator and is not currently or has not been previously on hemodialysis for at least 1 year. Participants with other stable medical disorders such as controlled diabetes, hyperlipidemia, hypothyroidism, arterial hypertension etc., may be eligible as long as they are considered appropriate for enrollment as determined by the Investigator by past medical history, physical examination, ECG, and clinical laboratory tests at Screening.
• Healthy control participants (Group 2)
• Each healthy participant must match the age (± 10 years), body weight (± 20%), race, ethnicity and sex of an individual participant in Group 1.
• Must weigh at least 50 kg to participate in the study and must have a BMI within the range of 18.0 to 35.0 kg/m2 inclusive, at Screening.

You may not qualify if:

• 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.
• Known or suspected diagnosis of Gilbert's syndrome.
• Participants with severe RI (Group 1)
• Clinically significant abnormal findings in physical examination, ECG, or clinical laboratory evaluations, extending over findings related to the known renal disease.
• Participants having had myocardial infarction \< 2 years of Screening are not eligible to participate, participants having had myocardial infarction greater than or equal to 2 years of Screening can be eligible to participate.
• Clinically significant illness within 2 weeks prior to first dosing that may jeopardize safety of the study participant and/or alter the study results as judged by the Investigator.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Clinical Pharmacology of Miami LLC

Miami, Florida, 33014-3616, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Genesis Clinical Research

Tampa, Florida, 33614, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 22, 2025
• Study Start: July 23, 2025
• Primary Completion: October 12, 2025
• Study Completion: October 14, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)