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Phase 1 study of remibrutinib exposure in cerebrospinal fluid after oral dosing in healthy participants

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What is this study about?

The study examines how the oral tablet of remibrutinib (200 mg) is absorbed and reaches the fluid surrounding the brain and spinal cord in people who are otherwise healthy, and it compares this with a matching placebo. The aim is to learn how much of the medicine enters the cerebrospinal fluid after taking the drug for a short period.

Participants will take the study medication once daily for five doses over 2½ days. On the third day a single sample of the fluid around the spinal cord will be taken using a quick procedure called a lumbar puncture, performed at a set time after the dose. Blood samples will also be collected to understand the drug’s movement in the body, known as its pharmacokinetic profile. Throughout the study, basic health checks such as vital signs, an electrocardiogram, and a safety laboratory assessment will be done, and any adverse events will be recorded up to 30 days after the last dose.

1 enrollment and randomization

upon enrollment you are assigned to receive either remibrutinib or a placebo tablet. the assignment is done in a blinded manner, so you will not know which one you receive.

2 first dose (day 0)

take one 200 mg remibrutinib film‑coated tablet (or matching placebo) by mouth with water. record the exact time the tablet is taken.

a brief safety check, including vital signs, may be performed before the dose.

3 subsequent doses (days 1‑2)

take the same tablet once daily for the next two days, for a total of five doses over 2.5 days.

each dose is taken by mouth with water, and the time of intake is recorded.

short safety assessments, such as checking blood pressure and heart rate, may be done before each dose.

4 final dose and lumbar puncture (day 3)

take the fifth tablet as instructed.

shortly after the dose you will undergo a lumbar puncture, which is a procedure that collects cerebrospinal fluid from the lower back.

the fluid collection occurs at one of three possible times after the dose: 30 minutes, 1 hour, or 2 hours, as specified by the study protocol.

5 blood sampling for pharmacokinetic and safety analysis

blood samples are taken at several time points, including before the first dose, after each dose, and after the lumbar puncture, to measure drug levels and assess safety.

the samples are used to calculate parameters such as peak concentration and half‑life of the drug.

6 ongoing safety monitoring

throughout the dosing period and for up to 30 days after the last dose, vital signs, electrocardiogram (a test that records the heart’s electrical activity), and laboratory tests are performed to monitor safety.

any adverse events, or unwanted medical occurrences, are recorded and evaluated.

7 final follow‑up visit (approximately day 30)

a final visit is scheduled about 30 days after the last dose to complete safety assessments and collect any remaining study data.

Who Can Join the Study?

  • Provide a signed informed consent, which is a written agreement that you understand the study and agree to take part.
  • Be able to read, speak, and understand the local language (or English) and follow the study’s requirements.
  • Be a healthy male or female who cannot become pregnant, aged 18 to 55 years, and considered in good health based on medical history, physical exam, neurological exam, vital signs (measurements like blood pressure and temperature), an electrocardiogram (ECG) (a simple heart test), and laboratory tests.
  • Have normal vital signs after resting lying down for at least 5 minutes:
    systolic blood pressure (the top number) between 90 and 139 mmHg,
    diastolic blood pressure (the bottom number) between 50 and 89 mmHg,
    pulse rate (heart beats per minute) between 45 and 90 beats per minute,
    and body temperature between 35.0°C and 37.5°C.
  • Weigh at least 50 kg and have a body mass index (BMI) between 18 and 30 kg/m² (BMI is calculated as weight in kilograms divided by height in meters squared).

Who Cannot Join the Study?

  • If a heart test called a ECG shows an abnormal result that the doctor thinks is important, you cannot join the study.
  • If you have taken any prescription drugs (except those allowed by the study), cannabis/marijuana, over‑the‑counter medicines (like aspirin) or herbal supplements in the last four weeks, you cannot join. A small amount of acetaminophen (paracetamol) is allowed only if it is recorded.
  • If you have taken any dietary supplements (including vitamins) in the last two weeks, you cannot join the study.
  • If a blood test shows your hemoglobin level (the protein that carries oxygen in your blood) is lower than the normal range, you cannot join.
  • If you smoke and a urine test shows a cotinine level (a marker that indicates nicotine use) of 500 ng/mL or higher, you cannot join.
  • If you have any illness that has not fully healed and the doctor believes it could affect the study’s results, you cannot join.
  • If you have a medical or surgical condition that might change how the drug is absorbed, distributed, broken down, or removed from your body, or that could put you at risk, you cannot join.
  • If blood tests show that liver enzymes such as ALT, AST, GGT, or ALP are more than 1.2 times the normal upper limit, or if bilirubin is 1.5 times the normal limit, or if more than one of these values is above normal, you cannot join.
  • If kidney tests show abnormal creatinine, blood urea, or urine results indicating reduced renal function, you cannot join the study.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Ppgmvqfgvuciye Rxnkpmaz Aaaovpjseq Geilp Biat Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
20.12.2023

Trial locations

Investigated Drugs:

remibrutinib is an oral medication taken as a film‑coated tablet. In this study healthy volunteers received the drug for a short period (five doses over 2.5 days) to see how much of it reaches the cerebrospinal fluid, the liquid that surrounds the brain and spinal cord. By measuring the drug’s concentration in this fluid, researchers can learn whether remibrutinib can enter the central nervous system, which is important for understanding its potential use in treating diseases that affect the brain or nerves.

Investigated Diseases:

Trial ID:
2023-506760-13-00
Protocol code:
CLOU064C12101
Trial Phase:
Human Pharmacology (Phase I) – Other

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