NCT05019755Unknown1 期
A Randomized, Open-label, Single-dose, 2-way Crossover Clinical Trial to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax of IN-A002(IN-115314)
研究概览
简要总结
This study aims to investigate the effect of food on the pharmacokinetics of IN-A002 capsule in healthy male subjects
详细描述
To explore the effect of High-fat diet on the pharmacokinetics of single dose of IN-A002 capsule in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
- •Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m^2 with a body weight ≥ 50.0 kg and ≤ 90.0 kg at screening. BMI (kg/m^2) = Weight(kg) / {Height(m)}^2
- •Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure.
- •Determined eligible for this study in the opinion of the investigator based on the results of vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests, and medical interview.
排除标准
- •Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- •Has a history or current evidence of gastrointestinal disease that may affect the safety and Pharmacokinetics assessment of investigational product(IP) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- •Has rheumatoid arthritis or has a history.
- •Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
- •Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
- •Has a history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of Janus kinase inhibitor and other drugs.
- •Has a positive result on serology tests (for hepatitis B, hepatitis C and human immunodeficiency virus [HIV], syphilis) during screening test.
- •Has abnormalities one or more of the following during screening test: AST [GOT] or ALT [GPT] > 1.5 X upper limit of normal (ULN), Creatinine > upper limit of normal (ULN), ANC < 2,000/uL, Hb < 12.5 g/dL, Platelet < 150,000/uL, QTc interval at 12-lead electrocardiogram > 450 msec
- •Systolic blood pressure (SBP) < 90 mmHg or > 140 mmHg, diastolic blood pressure (DBP) < 50 mmHg or > 95 mm Hg, or pulse rate (PR) < 45 beats/ min or > 100 beats/min on vital signs measured in sitting position after taking a rest for at least 5 minutes during screening test.
- •Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
- •Has taken any prescription drugs or herbal medicine within 2 weeks prior to the expected date of first dose, or any over-the-counter (OTC) drug, health functional food or vitamin preparation within 1 week prior to the scheduled first dose (However, can participate in the study if otherwise eligible in the judgment of the investigator) or is expected to take such medication during the study.
- •Has participated in any other clinical study, etc. and received IPs within 6 months prior to the scheduled first dose.
- •Has donated whole blood within 2 months prior to the scheduled first dose, or has donated blood components or received transfusion within a month prior to the scheduled first dose.
- •Has a history of excessive smoking (> 10 cigarettes/day) within 3 months prior to the scheduled first dose or confirmed as positive for cotinine on urine drug screening test.
- •Excessive caffeine intake (> 5 units/day) or continued use of alcohol (> 21 units/week, 1 unit = 10 g of pure alcohol).
- •Unable to stop drinking within 24 hrs prior to the scheduled first dose to post study visit.
- •Unable to avoid caffeine-containing foods (e.g., coffee, tea [black tea, green tea, etc.], soda, coffee-flavored milk, and nutritive tonic drink, etc.) and foods containing grapefruit during each period from 24 hrs before hospitalization to discharge.
- •Unable to use a medically acceptable contraceptive method stated below and does not agree not to donate sperm from the scheduled first dose to 90 days after the last dose.
- •Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)
- •Simultaneous use of (male or female) barrier method and spermicide
- •Surgical sterilization of the subject or his partner (e.g., vasectomy, salpingectomy, tubal ligation, or hysterectomy)
- •Determined ineligible for study participation by the investigator for other reasons.
研究组 & 干预措施
A(First period) to B(Second period) order
Experimental
A: Oral Administration of IN-A002(IN-115314) in fasting status
B: Oral Administration of IN-A002(IN-115314), 30 minutes after high-fat diet
There will be a wash out period of 7days between period
干预措施: IN-A002(IN-115314) capsule (Drug)
B(First period) to A(Second period) order
Experimental
B: Oral Administration of IN-A002(IN-115314), 30 minutes after high-fat diet
A: Oral Administration of IN-A002(IN-115314) in fasting status
There will be a wash out period of 7days between period
干预措施: IN-A002(IN-115314) capsule (Drug)
结局指标
主要结局
Cmax of IN-A002(IN-115314)
时间窗: up to 72 hours
AUClast of IN-A002(IN-115314)
时间窗: up to 72 hours
次要结局
- AUCinf of IN-A002(IN-115314)(up to 72 hours)
- Vd/F of IN-A002(IN-115314)(up to 72 hours)
- Cmax of IN-116118(primary metabolite of IN-A002(IN-115314))(up to 72 hours)
- AUClast of IN-116118(primary metabolite of IN-A002(IN-115314))(up to 72 hours)
- AUCinf of IN-116118(primary metabolite of IN-A002(IN-115314))(up to 72 hours)
- Tmax of IN-116118(primary metabolite of IN-A002(IN-115314))(up to 72 hours)
- t1/2 of IN-116118(primary metabolite of IN-A002(IN-115314))(up to 72 hours)
- λz of IN-116118(primary metabolite of IN-A002(IN-115314))(up to 72 hours)
- Metabolite ratio of IN-116118(primary metabolite of IN-A002(IN-115314))(up to 72 hours)
- Tmax of IN-A002(IN-115314)(up to 72 hours)
- t1/2 of IN-A002(IN-115314)(up to 72 hours)
- λz of IN-A002(IN-115314)(up to 72 hours)
- CL/F of IN-A002(IN-115314)(up to 72 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519(CKD-519 FDI)DyslipidemiaNCT02484482Chong Kun Dang Pharmaceutical45
已完成
1 期
Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy SubjectsHealthy VolunteerNCT04204629Hanmi Pharmaceutical Company Limited25
已完成
1 期
Food Effect Study of Linerixibat Tablets in Healthy Adult ParticipantsPruritusNCT05435170GlaxoSmithKline23
已完成
1 期
A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy ParticipantsHealthyNCT04258189Janssen Research & Development, LLC16
已完成
1 期
Study to Assess the Food Effect of K-877 in Healthy Adult VolunteersHealthyNCT04742218Kowa Research Institute, Inc.18