DDI Study of Orelabrutinib

Healthy Person Clinical Trial

Official title:

A Phase I, Single-center, Open-label, Fixed-sequence Clinical Study to Evaluate the Effects of Multiple Administrations of Rifampin or Itraconazole on the Pharmacokinetic Characteristics of a Single Administration of Orelabrutinib Tablets in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316857
• Other study ID #: ICP-CL-00117
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2021
• Est. completion date: June 13, 2022

Study information

• Verified date: June 2022
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 13, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy Person

Intervention

Drug:
• Orelabrutinib + Rifampin
Orelabrutinib + Rifampin
• Orelabrutinib + Itraconazole
Orelabrutinib + Itraconazole

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)	up to 3 months
Secondary	Tmax	To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include Time to Maximum Plasma Concentration(Tmax)	up to 3 months
Secondary	Incidence of Treatment-Emergent Adverse Events	To evaluate the safety and tolerability of Orelabrutinib	up to 3 months