Status:
COMPLETED
DDI Study of Orelabrutinib
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Healthy Person
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 pharmacoki...
Eligibility Criteria
Inclusion
- 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;
- Male or female subjects aged between 18 and 45 years old (inclusive) at the time of screening;
- 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);
- Be able to communicate well with investigator, and understand and comply with the requirements of this study.
Exclusion
- Complete physical examination, routine laboratory tests, cardiac color ultrasound and other examinations are abnormal with clinical significance;
- Hepatitis B surface antigen or E antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody are positive;
- C-reactive protein for novel coronavirus screening is abnormal with clinical significance, or the novel coronavirus nucleic acid testing is positive;
- Have received any drugs and therapy which are in the study protocol within 1 month before screening
- 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
- Have any history of clinically serious diseases, or diseases or conditions that the investigator believes may affect the results of the study.
- 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;
- Other subjects judged by the investigator as unsuitable to participate in this study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05316857
Start Date
December 16 2021
End Date
June 13 2022
Last Update
July 6 2022
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000