DDI Study of Orelabrutinib

NCT ID: NCT05316857

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2022-06-13

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.

Conditions

Healthy Person

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Orelabrutinib + Rifampin

Orelabrutinib is a white, round, uncoated table,Subjects take high dose orelabrutinib in the first day and the tenth day.

Rifampin is a capsule,Subjects take 600mg QD rifampin in the third day to the eleventh.

Group Type: OTHER

Orelabrutinib + Rifampin

Intervention Type: DRUG

Orelabrutinib + Rifampin

Orelabrutinib + Itraconazole

Orelabrutinib is a white, round, uncoated table,Subjects take low dose orelabrutinib in the first day and the eighth day.

Itraconazole is a capsule,Subjects take 600mg QD rifampin in the third day to the tenth.

Group Type: OTHER

Orelabrutinib + Itraconazole

Intervention Type: DRUG

Orelabrutinib + Itraconazole

Interventions

Orelabrutinib + Rifampin

Orelabrutinib + Rifampin

Intervention Type: DRUG

Orelabrutinib + Itraconazole

Orelabrutinib + Itraconazole

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

ICP-CL-00117

Identifier Type: -

Identifier Source: org_study_id