A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers

NCT ID: NCT06492525

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2024-12-31

Brief Summary

The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort 1

All subjects in this cohort will receive the same dose of Ensartinib in both periods. Subjects will receive Ensartinib Alone in Period 1 followed by Ensartinib with Rifampicin in Period 2.

Group Type: EXPERIMENTAL

Ensartinib

Intervention Type: DRUG

225 mg oral dose on day 1 in period 1 and on day 18 in period 2

Rifampicin

Intervention Type: DRUG

600 mg QD from day 9 to day 22 in period 2

Cohort 2

All subjects in this cohort will receive the same dose of Ensartinib in both periods. Subjects will receive Ensartinib Alone in Period 1 followed by Ensartinib with Itraconazole in Period 2.

Group Type: EXPERIMENTAL

Itraconazole

Intervention Type: DRUG

200 mg QD from day 9 to day 19 in period 2

Ensartinib

Intervention Type: DRUG

100 mg oral dose on day 1 in period 1 and on day 12 in period 2

Interventions

Ensartinib

225 mg oral dose on day 1 in period 1 and on day 18 in period 2

Intervention Type: DRUG

Rifampicin

600 mg QD from day 9 to day 22 in period 2

Intervention Type: DRUG

Itraconazole

200 mg QD from day 9 to day 19 in period 2

Intervention Type: DRUG

Ensartinib

100 mg oral dose on day 1 in period 1 and on day 12 in period 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
• Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
• The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
• Able to comprehend and willing to sign an informed consent form.

Exclusion Criteria

• Those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion；
• Family history or presence of long QTc syndrome; History or presence of an abnormal ECG；
• Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody or human immunodeficiency virus antigen/antibody (HIV-Ag/Ab) is positive；
• Use of any medications (prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, moderate or strong CYP3A inhibitors or inducers, etc) within 14 days prior to the first administration；
• Those who have special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages) and are unable to withdraw during the trial；
• Drug abusers, smokers or alcoholics；
• Those with a history of fear of needles and hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection;
• Donation of blood ≥ 400 mL or receipt of blood products within 3 months before enrollment;
• Receive any vaccine within 1 months before enrollment；
• Participation in any other investigational drug study within 3 months before enrollment；
• History of significant hypersensitivity to any drug compound or food；
• Other conditions that, in the opinion of the investigator, are not suitable for the subject to participate in this study.

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

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Bo Jiang, Ph.D

Role: CONTACT

jiangbo@zju.edu.cn

0571-87783759

Other Identifiers

BTP-42319

Identifier Type: -

Identifier Source: org_study_id