Healthy Person
Conditions
Brief summary
This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects.
Interventions
DRUGOrelabrutinib + Rifampin
Orelabrutinib + Rifampin
DRUGOrelabrutinib + Itraconazole
Orelabrutinib + Itraconazole
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject who can fully understand the objectives, nature, methods and possible adverse reactions of the trial, and volunteers to be the subject, and has signed an informed consent form before the start of any study procedure, and guarantees that any procedure will be participated in by himself/herself; 2. Male or female subjects aged between 18 and 45 years old (inclusive) at the time of screening; 3. Body weight ≥50 kg for male subjects, ≥45 kg for female subjects, and a body mass index (BMI) of 19 to 26.0 kg/m2 (inclusive); 4. Be able to communicate well with investigator, and understand and comply with the requirements of this study.
Exclusion criteria
1. Complete physical examination, routine laboratory tests, cardiac color ultrasound and other examinations are abnormal with clinical significance; 2. Hepatitis B surface antigen or E antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody are positive; 3. C-reactive protein for novel coronavirus screening is abnormal with clinical significance, or the novel coronavirus nucleic acid testing is positive; 4. Have received any drugs and therapy which are in the study protocol within 1 month before screening 5. Have taken prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicine within 14 days before the first administration of the investigational drug 6. Have any history of clinically serious diseases, or diseases or conditions that the investigator believes may affect the results of the study. 7. Subject who has a childbirth plan during the study period and within 3 months after the end of the study, or the subject and his/her partner do not agree to take strict contraceptive measures during this period; 8. Other subjects judged by the investigator as unsuitable to participate in this study NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | up to 3 months | To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include the peak plasma concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | up to 3 months | To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include Time to Maximum Plasma Concentration(Tmax) |
| Incidence of Treatment-Emergent Adverse Events | up to 3 months | To evaluate the safety and tolerability of Orelabrutinib |
Countries
China
Outcome results
None listed