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

Launched by BETTA PHARMACEUTICALS CO., LTD. · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how two medications, rifampicin and itraconazole, affect the way the body processes a drug called ensartinib. Ensartinib is being studied to understand its effects better, and this trial will help researchers learn more about how these other medications might change how ensartinib works in the body. The study is aimed at healthy volunteers aged 18 to 65, and it will not be recruiting participants until later.

To be eligible for this trial, participants need to be healthy men or women within a specific weight and body mass index range. They should not have any serious health issues, especially those affecting the heart, liver, or kidneys. Participants will need to agree to use effective birth control during the study and for three months after it ends. Throughout the trial, volunteers can expect to take the study medication and undergo regular check-ups to monitor their health. It's important for potential participants to know that they cannot take certain medications or have specific dietary habits that may interfere with the study.

Gender

ALL

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.