DDI Study of Orelabrutinib

NCT05316857 | Completed Phase 1

• 1 other identifier: ICP-CL-00117
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tmax

  up to 3 months

• Incidence of Treatment-Emergent Adverse Events

  up to 3 months

Study Arms (2)

Orelabrutinib + Rifampin

OTHER

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 + Itraconazole

OTHER

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

Interventions

Orelabrutinib + Rifampin DRUG

Orelabrutinib + Rifampin

Orelabrutinib + Rifampin

Orelabrutinib + Itraconazole DRUG

Orelabrutinib + Itraconazole

Orelabrutinib + Itraconazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Interventions

orelabrutinib; Rifampin; Itraconazole

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 7, 2022
• Study Start: December 16, 2021
• Primary Completion: January 4, 2022
• Study Completion: June 13, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

CN (1)