ACTRN12620001127998已完成1 期
An open-label, randomised, three-arm crossover study to assess the absorption characteristics of different dosing strategies for ManNAc in healthy adult males
niversity of South Australia0 个研究点目标入组 12 人开始时间: 2020年10月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 59 Years（—）
- 性别
- Male
入选标准
- •1. The participant is a male aged 18-59 years, inclusive.
- •2. Body mass index (BMI) is between 18-30 kg/m2 with a body weight between 45-120 kg.
- •3. Medically healthy without any clinically significant abnormalities. Health status will be determined by the participant's medical history with specific attention to: (I) drug history identifying any known drug allergies or drug abuse, (II) any chronic use of medication, and (III) a thorough review of body systems (vital signs including an electrocardiogram (ECG), physical examination and clinical laboratory assessment).
- •4. Adequate venous access on their left or right arm to allow for collection of multiple blood samples.
- •5. The participant is aware of the study procedures and the risks involved, and voluntarily agrees to participate by providing written informed consent.
- •6. The participant is willing and able to understand the study procedures and communicate effectively with study personnel.
- •7. The participant is willing to be confined to the Clinical Trial Facility for the specified study days.
排除标准
- •1. History of clinically significant central nervous system (e.g. seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions, or history of any conditions that in the opinion of the Medical Officer, may pose an unacceptable level of risk to either the participants ort study staff, may interfere with the interpretation of safety and/or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of the study compound.
- •2. History of hypersensitivity to ManNAc or dietary salt or in the judgment of the Medical Officer, has a condition that places the participant at increased risk for adverse effects.
- •3. Consumption of an investigational medication or a new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment.
- •4. The participant has been treated with ManNAc, sialic acid, intravenous immunoglobulin (IVIG), and/or other supplements containing sialic acid (e.g. St. John’s Wort, sialyllactose) less than 120 days prior to administration of the study compound.
- •5. Difficulty of refraining from prescription medications and/or over the counter (OTC) products, which in the opinion of the Medical Officer might affect the results of the study or safety of the participant.
- •6. Donation of blood or blood products in excess of 550 mL within 12 weeks prior to administration of study medication.
- •7. History or current evidence of alcohol abuse and/or difficulty in abstaining from alcohol for 24 h prior to dose administration until the completion of blood sampling in each study period.
- •8. History or current evidence of drug abuse, positive urine drug screen during screening, and/or difficulty in abstaining from drugs of abuse throughout the entire study.
- •9. Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines (I.e. coffee, tea, cola, energy drinks and chocolate) for 24 h prior to dose administration until the completion of blood sampling in each study period.
- •10. Major surgery within 4 weeks of screening.
- •11. Uncontrolled intercurrent illness (i.e. active infection).
- •12. Tobacco users who are unable to refrain from smoking whilst confined in the Clinical Trial Facility each study day.
- •13. Difficulty in refraining from food and fluid (excluding water) consumption from 2200 h the night before dosing (I.e. for 10 h prior to dosing) until up to 5 h after the initial dose each treatment period.
- •14. The participant has specific dietary requirements that prevents the consumption of a standardised meal.
- •15. Poor compliers or those who are unlikely to attend specified study days.
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