DDI Study of Orelabrutinib

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Person
• Intervention / Treatment: Drug: Orelabrutinib + Rifampin; Drug: Orelabrutinib + Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Drug: Orelabrutinib + Rifampin; Orelabrutinib + Rifampin
OTHER: 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.	Drug: Orelabrutinib + Itraconazole; Orelabrutinib + Itraconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of Treatment-Emergent Adverse Events	To evaluate the safety and tolerability of Orelabrutinib	up to 3 months

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2021
• Primary Completion (ACTUAL): January 4, 2022
• Study Completion (ACTUAL): June 13, 2022

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (ACTUAL): April 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; 14-alpha Demethylase Inhibitors; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Itraconazole
• Other Study ID Numbers: ICP-CL-00117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No