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

Betta Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Ensartinib; Drug: Rifampicin; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06492525

BTP-42319

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Rifampicin

Drug: Ensartinib

Drug: Ensartinib

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Itraconazole

Drug: Ensartinib

Drug: Ensartinib