NCT04733001已完成1 期
A Randomized, Open-label, Single Dose, 3-way Crossover Clinical Trial to Investigate the Effect of Food on the Pharmacokinetics of HSG4112 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Glaceum
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
研究概览
简要总结
- Study Objective: The objective of this clinical trial is to investigate the effect of food on the pharmacokinetics of HSG4112 after oral administration in healthy male subjects.
- Study Design and Plan: This study is a randomized, open-label, single dose, 3-way crossover clinical trial. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. A total of 12 subjects will be randomized to 6 different sequence groups. Each subject will receive a single dose of HSG4112 480 mg via oral administration under fasted, low-fat diet, and high-fat diet conditions, with a washout period of 21 days in between each dosing.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
- •Males between 19 and 50 years of age at screening.
- •Body mass index (BMI) between 18 and 26.
- •☞ BMI (kg/m2) = Body weight (kg) / {Height (m)^2}
- •In good health, determined by no clinically significant findings from medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
排除标准
- •Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, or cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder).
- •History of stomach or intestinal disorders (e.g., Chrons disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the safety or pharmacokinetic evaluation of the investigational product.
- •Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice, aspirin, antibiotics).
- •One of more of the following laboratory test results at screening:
- •ALT (SGPT) > 60 IU/L
- •Glucose (fasting) > 110 mg/dL or < 70 mg/dL
- •Testosterone < 2.49 ng/mL or > 8.36 ng/mL
- •Systolic blood pressure of < 90 mmHg or > 150 mmHg, or diastolic blood pressure of < 60 mmHg or > 100 mmHg as determined by vital signs monitored after resting in sitting position for at least 3 minutes.
- •History of drug/chemical abuse or tested positive in urine drug screen.
- •Use or intend to use any prescription medications/products or phytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins within 7 days prior to dosing, unless deemed acceptable by the Investigator.
- •Participation in any clinical study or bioequivalence study involving administration of an investigational drug, including any study investigating HSG4112, within 6 months prior to dosing (i.e., within 6 months of the last dose from the previous study).
- •Whole blood donation within 2 months prior to dosing, plasma/platelet donation within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing.
- •Smoked > 10 cigarettes per day within 90 days prior to dosing.
- •Alcohol consumption of > 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
- •Ingestion of grapefruit-containing foods or beverages 24 hours prior to dosing until discharge, or unable to abstain from ingesting such foods or beverages during the same period.
- •Unable to abstain from caffeine-containing foods or beverages (e.g., coffee, tea (e.g., black tea, green tea), soft drinks, coffee milk, energy drinks, sports drinks) during the admission period.
- •Unable or unwilling to use acceptable contraceptive methods during the study period.
- •☞ Acceptable contraceptive methods include:
- •Use of an intrauterine device, which has been proven highly effective, by the subject's spouse/partner.
- •Physical contraception for subject or spouse/partner used with chemical sterilization.
- •Surgical sterilization (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy) of the subject or the subject's spouse/partner.
- •Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.
研究组 & 干预措施
HSG4112 Treatment Arm: Fasted
Experimental
Single oral dosing of HSG4112 480 mg under fasted conditions
干预措施: HSG4112 (Drug)
HSG4112 Treatment Arm: Low-Calorie Diet
Experimental
Single oral dosing of HSG4112 480 mg under low-calorie (400-500 kcal with 100-125 kcal fat) diet conditions
干预措施: HSG4112 (Drug)
HSG4112 Treatment Arm: High-Calorie Diet
Experimental
Single oral dosing of HSG4112 480 mg under high-calorie (800-1000 kcal with 500-600 kcal fat) diet conditions
干预措施: HSG4112 (Drug)
结局指标
主要结局
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
时间窗: Hour 0 to 24
Area under the plasma concentration-time curve of HSG4112 over dosing interval (AUCtau)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point
时间窗: Hour 0 to 192
Area under the plasma concentration-time curve from time zero to the last measurable point (AUClast)
Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112
时间窗: Hour 0 to 192
Maximum plasma concentration of HSG4112 (Cmax)
次要结局
- Pharmacokinetic Assessment by Half-Life of HSG4112(Hour 0 to 192)
- Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity(Hour 0 to 192)
- Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112(Hour 0 to 192)
- Pharmacokinetic Assessment by Oral Clearance of HSG4112(Hour 0 to 192)
- Pharmacokinetic Assessment by Volume of Distribution of HSG4112(Hour 0 to 192)
研究者
研究点 (1)
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