NCT07517913尚未招募不适用
Cerebrospinal Fluid Kinetics of Urolithin A in Humans
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Amazentis SA
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- CSF:plasma ratio
研究概览
简要总结
The purpose of this study is to determine the impact of Mitopure® consumption on urolithin A (UA) kinetics in cerebral spinal fluid (CSF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Healthy male and female human participant aged between 18 and 45 years (both inclusive);
- •Participants with a body mass index (BMI) between 18.50-30.00 kg/m2
- •and body mass, not less than 50.00 kg;
- •Female participant must have a negative urine pregnancy test prior to the housing;
- •Females of childbearing potential agreeing to use appropriate
- •contraceptive measures like non hormonal intrauterine device, barrier methods, spermicidal agents during the study and 07 days after completion of the study;
- •Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study;
- •Participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests);
- •Participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording;
- •Participants having a normal or clinically not significant chest X-ray (PA view);
- •A negative alcohol breath test result;
- •Participant able to communicate effectively and provide written informed consent;
- •Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee;
- •Participants that can provide adequate evidence of their identity;
- •Availability of volunteers for the entire study duration;
- •Ability to fast for at least 14.00 hours and consume standard meals.
- •Participants with normal hemoglobin levels as follows: Males:14 to 18 g/dl (both inclusive); Females: 12 to 16 g/dl (both inclusive).
排除标准
- •Known hypersensitivity to Urolithin A or related product or any component of this intervention;
- •Incapable of understanding the informed consent information;
- •Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, pulmonary, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities;
- •Any treatment which could bring about induction or inhibition of the
- •hepatic microsomal enzyme system within one month of starting the study;
- •History or presence of alcoholism or drug abuse;
- •History or presence of asthma, urticaria, or other allergic reactions;
- •History or presence of gastric and/or duodenal ulceration;
- •History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion;
- •History or presence of cancer;
- •Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study;
- •Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study;
- •Smokers who smoke 9 or more cigarettes/day or inability to abstain
- •during the study;
- •Participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours before initiation of the study and throughout the study;
- •Major illness during the 90 days before screening;
- •Participation in a drug research study within 90 days of screening;
- •Donation of blood within 90 days of screening;
- •Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL;
- •History or presence of easy bruising or bleeding;
- •Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study;
- •Females of childbearing potential with any one of the following reported and documented on the medical history:
- •Postmenopausal with spontaneous amenorrhea for at least one year, or
- •Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- •Total hysterectomy and an absence of bleeding for at least 3 months.
- •Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing;
- •Pregnant women and nursing mothers;
- •Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study.
- •Allergy to peanuts, nuts, pea, or gum guar
研究组 & 干预措施
Biospecimen Time 3
Experimental
Cerebrospinal fluid will be collected at timepoint 3
干预措施: Placebo (Dietary Supplement)
Biospecimen Time 4
Experimental
Cerebrospinal fluid will be collected at timepoint 4
干预措施: Placebo (Dietary Supplement)
Biospecimen Time 5
Experimental
Cerebrospinal fluid will be collected at timepoint 5
干预措施: Placebo (Dietary Supplement)
Biospecimen Time 4
Experimental
Cerebrospinal fluid will be collected at timepoint 4
干预措施: Mitopure (Dietary Supplement)
Biospecimen Time 3
Experimental
Cerebrospinal fluid will be collected at timepoint 3
干预措施: Mitopure (Dietary Supplement)
Biospecimen Time 2
Experimental
Cerebrospinal fluid will be collected at timepoint 2
干预措施: Mitopure (Dietary Supplement)
Biospecimen Time 1
Experimental
Cerebrospinal fluid will be collected at timepoint 1
干预措施: Mitopure (Dietary Supplement)
Biospecimen Time 5
Experimental
Cerebrospinal fluid will be collected at timepoint 5
干预措施: Mitopure (Dietary Supplement)
Biospecimen Time 2
Experimental
Cerebrospinal fluid will be collected at timepoint 2
干预措施: Placebo (Dietary Supplement)
Biospecimen Time 1
Experimental
Cerebrospinal fluid will be collected at timepoint 1
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
CSF:plasma ratio
时间窗: 24 hours
Participants will have their cerebral spinal fluid 1, 3, 6, 12, or 24 hours after Mitopure consumption. Outcome measure is the ratio of urolithin A concentration in cerebral spinal fluid:plasma
次要结局
未报告次要终点
研究者
研究点 (2)
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