Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol and Food Effect in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
This is a single-site, randomized, partly double-blind, placebo-controlled study of Aramchol in sixty six (66) healthy male volunteers.
In each part of the study subjects will be enrolled in the study within 28 days before drug administration(s).
The study will consist of three parts and the subjects will be assigned to three Parts.
详细描述
This is a single-site, randomized, partly double-blind, placebo-controlled study of Aramchol in sixty six (66) healthy male volunteers.
In each part of the study subjects will be enrolled in the study within 28 days before drug administration(s).
The study will consist of three parts and the subjects will be assigned to three Parts as follows:
Part A - single escalating doses:
The purpose of this part is to evaluate the pharmacokinetics, safety and tolerability of Aramchol tablets at single doses of either 200 mg or 400 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, males subjects between 18-50 years (inclusive)
- •21.0<BMI< 29.9kg/m2
- •Non-smoking (by declaration) for a period of at least 3 months before screening visit.
- •Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
- •No significant abnormalities in ECG (e.g. prolonged QTC, prolonged PR interval) done at screening and on Days (0) before dosing session.
- •No clinically significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at screening.
- •No known history of alcohol or drug abuse. Subjects with negative urinary drugs of abuse screen determined on Day (0) before dosing session(s)
- •Negative HIV, hepatitis B or hepatitis C serology tests as evaluated at screening.
- •Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Subjects must agree to use adequate birth control measures (condom in combination with a spermicidal gel or foam) during the study and up to 15 days after the last study drug administration.
- •Subjects must satisfy a medical examiner about their fitness to participate in the study.
- •Subjects must provide written informed consent to participate in the study.
排除标准
- •Documented history or on-going symptoms of any gastrointestinal disorder involving motility, gastric acid or gastric emptying or malabsorption, including but not limited to, peptic ulcer disease, gastroesophageal reflux, dyspepsia, gastroparesis, chronic diarrhea, chronic constipation, gall bladder disease, pancreatitis, lactose intolerance and celiac disease.
- •History of esophageal, gastric, biliary, or intestinal surgery (excluding herniotomy and appendectomy which are not related to gastrointestinal disorders).
- •Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- •Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit.
- •Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
- •Subjects who have taken anticholinergic or other drugs known to affect gastrointestinal motility within 7 days prior to the first dosing
- •Treatment with any drugs with known hepatic enzyme-inducing or inhibiting agents (such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc.) within 30 days prior to dosing.
- •Known hypersensitivity and/or allergy to any drugs.
- •Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the study, or subjects with recent significant change in body weight
- •Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug administration, which is considered of significance by the Principal Investigator.
- •Participation in another clinical trial with drugs, received within 3 months prior to dosing (calculated from the previous study's last dosing date).
- •Subjects who donated blood in the three months or received blood or plasma derivatives in the six months preceding study drug administration.
- •Subjects with inability to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).
- •Inability to fast or consume the food provided in the study (including any known food allergies or food restrictions).
- •Subjects who are non-cooperative or unwilling to sign consent form.
研究组 & 干预措施
PART A (single dose)-200 mg
200 mg ARAMCHOL
干预措施: Aramchol (Drug)
PART A (single dose)-400 mg
400 mg ARAMCHOL
干预措施: Aramchol (Drug)
Part C ( multiple doses)- 200 mg
200 mg Aramchol tablets for ten consecutive days.
干预措施: Aramchol (Drug)
Part B ( food effect)- -Fasting
600 mg Aramchol tablets under fasting conditions (fasting for at least 10 hours before and 4 hours after dosing)
干预措施: Aramchol (Drug)
Part B ( food effect)- -Fed
600 mg Aramchol tablets under fed conditions (fasting for at least 10 hours before dosing, consumption of a high calorie high fat meal within 30 minutes prior to drug administration and no food for additional 4 hours after dosing)
干预措施: Aramchol (Drug)
Part C ( multiple doses)- 400 mg
400 mg Aramchol tablets for ten consecutive days.
干预措施: Aramchol (Drug)
Part C ( multiple doses)- 600 mg
600 mg Aramchol tablets for ten consecutive days.
干预措施: Aramchol (Drug)
Part C ( multiple doses)- Placebo
Placebo tablets for ten consecutive days.
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: Part C: day 1 and day 10
Area under the plasma concentration time curve (AUC)
时间窗: Part C: day 1 and day 10
次要结局
- Clinical laboratory safety tests(Part C:Dosing days 1 and 2: pre-dose (within 60 min before first dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18 and 24 (before second dosing) hours after drug administration+ day 3-10)
- Adverse event (AE) profile(Part C:Dosing days 1 and 2: pre-dose (within 60 min before first dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18 and 24 (before second dosing) hours after drug administration+ day 3-10)