A Phase I Clinical Study to Evaluate the Pharmacokinetic Profile and Safety of Lanifibranor After Single Dose and Multiple Doses in Healthy Adult Chinese Subjects

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2023年10月31日最近更新: 2024年1月2日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
入组人数: 24
试验地点: 1
主要终点: Maximum concentration (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Aged 18-45 years (both inclusive) at the time of signing the informed consent form (ICF), regardless of gender;
•Male subjects body weight ≥ 50 kg and female subjects body weight ≥ 45 kg, with a body mass index (BMI) of 18-28 kg/m2 (both inclusive);
•No clinically significant findings in medical history, physical examination, 12-lead ECG, vital signs, laboratory tests, etc.;
•Normal clinical laboratory test values at screening and baseline (Day 1) or judged as not clinically significant by the investigator and/or sponsor;
•Alanine aminotransferase ≤ 1.1 × upper limit of normal (ULN), aspartate aminotransferase ≤ 1.2 × ULN; normal renal function, estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2 at screening.
•Subjects need to understood the study, agree to voluntarily participate in the study, to comply with the study requirements, and provide written informed consent;
•Female subjects of childbearing potential must agree to use 2 highly effective methods of contraception, barrier contraception, during the study and within 30 days after one of which must be the study treatment. Female subjects must have a negative serum pregnancy test at screening and baseline (Day 1).
•Male subjects and their female partners of childbearing potential must agree to use 2 highly effective methods of contraception (as defined above), one of which must be a barrier method, during the study and for 90 days after receiving the study drug.

排除标准

•History or evidence of respiratory, circulatory, endocrine, urinary, digestive, immunological, reproductive, hematological, neurological, or psychiatric disorders, especially any history that may affect drug absorption, distribution, metabolism, and excretion.
•Subjects who are positive for any of the following: hepatitis B virus surface antigen (HBs-Ag), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), and treponema pallidum antibody (anti-TP).
•Subjects with any of the following conditions within 6 months prior to screening: Unstable body weight, Women with irregular menstruation or ovulation, including but not limited to women with Stein-Leventhal syndrome and perimenopausal women with abnormal ovulation, History of osteoporosis or fracture, History of oedema peripheral at any site, History of gallbladder disease, including but not limited to cholelithiasis, and cholecystitis, History of hypoglycemia or events highly suspicious of hypoglycaemia.
•Current tissue dysplasia or history of malignancy (including lymphoma and leukemia) within the past 5 years, except for successfully cured non-metastatic basal cell carcinoma or squamous cell carcinoma or localized cervical carcinoma in situ.
•Pregnant, lactating women, or women planning to become pregnant during the study or within 30 days of study drug administration.
•Treatment with another study drug or device within 3 months before study drug administration; or less than 5 half-lives from treatment with another study drug or device at screening, whichever is longer.
•Known hypersensitivity or intolerance to lanifibranor or any of the excipients, and allergic constitution.
•Consumption of more than 28 units of ethanol per week, or a history of alcohol abuse, at any time within 6 months prior to study drug administration.
•Smoking more than 5 cigarettes per day or consuming an equivalent amount of nicotine or nicotine-containing products within 6 months before screening, or an inability to discontinue the use of any tobacco products during the study.
•Taking prescription drugs (excluding oral and other contraceptives [e.g., long-acting formulations, transdermal contraceptives, and intrauterine devices]), including nonsteroidal anti-inflammatory drugs, sucralfate, drugs known to decrease metabolism or increase bioavailability, traditional Chinese medicine preparations, melatonin, or other nutritional supplements, within 14 days or 5 half-lives (whichever is longer) before study drug administration, or taking over-the-counter drugs, vitamins, or supplements (including cod-liver oil) within 7 days before study drug administration.
•Consuming products containing alcohol, caffeine, or xanthines, Seville oranges, and grapefruit or grapefruit juice within 72 hours prior to study drug administration.
•Engagement in strenuous activity (e.g., exercise) within 96 h (4 days) before admission to the clinical research unit (CRU) and throughout the study.
•Donation of more than 500 mL of blood or significant blood loss within 90 days prior to admission to the CRU.
•History or evidence of poor venous access or hemorrhagic disorder.
•History of drug use, drug abuse, or positive urine drug test.
•Any condition that, as determined by the investigator, may pose a safety risk to the subject during the study or may interfere with the study's conduct, or the investigator believes that the subject may not be able to complete the study or comply with its requirements.

研究组 & 干预措施

Lanifibranor 800 mg

Experimental

In Part A, lanifibranor 800 mg is given as a single dose (followed by 14 days follow-up).

In Part B, lanifibranor 800 mg is given once daily for 7 consecutive days (followed by 7 days follow-up).

干预措施: Lanifibranor (Drug)

Lanifibranor 120 mg

Experimental

In Part A, lanifibranor 1200 mg is given as a single dose (followed by 14 days follow-up).

In Part B, lanifibranor 1200 mg is given once daily for 7 consecutive days (followed by 7 days follow-up).

干预措施: Lanifibranor (Drug)