A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepat… (NCT05753592) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants
Hungary38 participantsStarted 2022-10-31
Plain-language summary
This was a Phase 1, open-label study to evaluate the PK, safety, and tolerability after administration of multiple doses of remibrutinib in participants with mild, moderate, or severe hepatic impairment (HI) compared to pooled matched healthy control participants with normal hepatic function.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent was obtained prior to participation in the study.
. Male and non-childbearing potential female\* participants 18 to 70 years of age, inclusive, at Screening.
. Women of non-childbearing potential were defined as women who were post menopausal or had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks prior to first dosing of study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman was confirmed by follow-up hormone level assessment was she considered not of childbearing potential. Women were considered post-menopausal if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms).
. Must have been a non-smoker or a light smoker who smoked no more than 10 cigarettes (or equivalent) per day, at Screening. Smokers must have agreed to smoke no more than 5 cigarettes (or equivalent) per day from check-in until after Study Completion evaluations.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Must have been able to communicate well with the investigator and to understand and comply with the requirements of the study.
. Must have weighed at least 50 kg to participate in the study and must have had a body mass index (BMI) within the range of 18.0 to 35.0 kg/m2, inclusive, at Screening.
. Seated vital signs must have been within the following ranges at Screening and Baseline:
. Had impaired hepatic function as defined by the Child-Pugh classification for severity of liver disease and had a Child-Pugh score in line with one of the following HI groups at Screening:
Exclusion criteria
. Use of other investigational drugs within 5 half-lives or 30 days prior to first dosing of study treatment, whichever was longer.
. History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
. 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 was evidence of local recurrence or metastases.
. History of immunodeficiency diseases or had a positive human immunodeficiency virus (HIV) test result at Screening.
. History or presence of any ongoing, chronic, or recurrent infectious disease (including tuberculosis, atypical mycobacterioses, listeriosis, aspergillosis).
. Female participants who were of childbearing potential, defined as all women physiologically capable of becoming pregnant.
. Female participants who were pregnant or nursing (lactating). Pregnancy was defined as the state of a female participant after conception and until termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test at Screening or Baseline.
. Use of prohibited prescription or non-prescription medication or supplement.