health Subjects
Conditions
Interventions
Cohort A, Treatment Sequences 1:Treatment Periods 1 and 2 will be from Days 1 to 4 and Days 5 to 6, respectively. Days 1 to 3 and Day 5 will be the lead-in dosing phases. Day 4 and Day 6 will be the P
Cohort A, Treatment Sequences 2:Treatment Periods 1 and 2 will be from Days 1 to 4 and Days 5 to 6, respectively. Days 1 to 3 and Day 5 will be the lead-in dosing phases. Day 4 and Day 6 will be the P
Cohort B, Treatment Sequences 1:Treatment Periods 1 and 2 will be from Days 1 to 4 and Days 5 to 6, respectively. Days 1 to 3 and Day 5 will be the lead-in dosing phases. Day 4 and Day 6 will be the P
Cohort B, Treatment Sequences 2:Treatment Periods 1 and 2 will be from Days 1 to 4 and Days 5 to 6, respectively. Days 1 to 3 and Day 5 will be the lead-in dosing phases. Day 4 and Day 6 will be the P
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Healthy female of non-child-bearing potential and/or male participants within an age range between 18 to 55 years (inclusive) at screening. 3. Participants should be in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening and Baseline visit. 4. At Screening and Baseline, vital signs (systolic and diastolic blood pressure [BP] and pulse rate) will be assessed in the sitting position. Sitting vital signs should be within the following ranges: Temporal temperature of 35.0 to 37.5°C; systolic blood pressure (SBP) of 90 to 139 mmHg; diastolic blood pressure (DBP) of 50 to 89 mmHg; pulse rate of 50 to 100 bpm. If vital signs are out-of-range, the investigator may obtain two additional readings so that a total of up to three consecutive assessments are made, with the participant seated quietly for approximately five minutes preceding each repeat assessment. At least the last reading must be within the ranges provided above in order for the participant to qualify. 5. Participants must weigh at least 50 kg to participate in the study and must have a BMI within the range of 18 to 29.9 kg/m2 at Screening. BMI = Body weight (kg) / [Height (m)]2. 6. Able to communicate well with the investigator, to understand and comply with the requirements of the study
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study. 1. Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer; or longer if required by local regulations. 2. History of clinically significant ECG abnormalities (e.g. long QT syndrome, arrhythmia, or tachycardia), or any of the following ECG abnormalities at Screening or Baseline visit: PR > 220 msec; QRS complex > 120 msec; Fridericia QT correction formula (QTcF) > 450 msec (males) or QTcF > 460 msec (females); any other clinically relevant morphological changes, other than early repolarization, non-specific S-T or T-wave changes as per the judgement of the investigator. 3. Family history (grandparents, parents, or siblings) of a prolonged QT interval syndrome. 4. History of additional risk factors for Torsade de Pointes (e.g. heart failure, clinically significant hypokalemia per investigator judgment) and/or known history or current clinically significant arrhythmias. 5. Participant has a medically documented history of clinically significant hematologic, renal, endocrine, pulmonary, cardiovascular, or hepatic disease. 6. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or adequately treated cervical cancer, per investigator judgment), treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases. 7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test. 8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. Women are considered post?menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks prior to initial dosing. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential. 9. History of hypersensitivity to remibrutinib and/or any excipients of the study treatments. History of hypersensitivity to other BTK inhibitors. Excipients of remibrutinib: cellulose microcrystalline, sodium bicarbonate and magnesium stearate. 10. Redundant exclusion criterion was removed with Amendment 1. 11. Any clinically significant abnormalities in any of the standard coagulation tests including the prothrombin time (PT), partial thromboplastin time (PTT), or International Normalized Ratio (INR) at Screening or Baseline. 12. History or presence of any significant coagulation disorder, such as thrombocytopenia, hemophilia, or history of severe bleeding events, such as gastrointestinal or subarachnoidal bleeding or recurrent spontaneous bleeding. 13. Smokers (use of tobacco products in the previous 3 months prior to initial dosing) until completion of EOS evaluations (at least 7 days following the last dose). Smokers will be defined as any participant who reports tobacco use and/or who has a urine cotinine >= 500 ng/mL at Screening or Baseline. 14. Use of any prescription drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-12;Tmax;AUC0-4h;CL/F;Cmax; | — |
Countries
China
Contacts
Public ContactFeng Ping
West China Hospital of Sichuan University
Outcome results
None listed