Status:
NOT_YET_RECRUITING
A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06492525
Start Date
July 1 2024
End Date
December 1 2024
Last Update
July 9 2024
Active Locations (1)
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1
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009