A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
Phase 1
Not yet recruiting
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06492525
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 Ensartinib 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. Cohort 2 Ensartinib 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. Cohort 1 Rifampicin 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. Cohort 2 Itraconazole 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.
- Primary Outcome Measures
Name Time Method Plasma AUC0-∞ for Ensartinib Given Alone and With Itraconazole Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2. AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Plasma AUC0-t for Ensartinib Given Alone and With Rifampicin Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2. AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Plasma AUC0-t for Ensartinib Given Alone and With Itraconazole Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2. AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Plasma AUC0-∞ for Ensartinib Given Alone and With Rifampicin Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2. AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Plasma Cmax for Ensartinib Given Alone and With Rifampicin Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2. Maximum plasma concentration
Plasma Cmax for Ensartinib Given Alone and With Itraconazole Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2. Maximum plasma concentration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Second Affiliated hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China