Clinical trial NCT06492525: A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
Official title: A Phase 1, Open-label, 2-period, Fixed Sequence, Cross-over Study To Investigate The Effect Of Multiple Doses Of Rifampicin Or Itraconazole On The Pharmacokinetics Of Single Dose Ensartinib In Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 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.

Primary outcomes:
measure: Plasma AUC0-t for Ensartinib Given Alone and With Rifampicin
timeFrame: 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.
measure: Plasma AUC0-t for Ensartinib Given Alone and With Itraconazole
timeFrame: 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.
measure: Plasma AUC0-∞ for Ensartinib Given Alone and With Rifampicin
timeFrame: 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.
measure: Plasma AUC0-∞ for Ensartinib Given Alone and With Itraconazole
timeFrame: 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.
measure: Plasma Cmax for Ensartinib Given Alone and With Rifampicin
timeFrame: 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.
measure: Plasma Cmax for Ensartinib Given Alone and With Itraconazole
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: