A comparative pharmacokinetic profiles of Urolithin A formulations in healthy volunteers: a randomized, open-label, single-dose, parallel-arm study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Amazentis SA
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Plasma Pharmacokinetics parameters of all three Urolithin A formulations
研究概览
简要总结
Functional food and food supplements that have been precisely calibrated to deliver bioactive natural ingredients are a desirable way to unlock health benefits to a wider target population, i.e., those unable to derive the benefits of dietary components that impart various health promoting benefits. Amazentis has developed a food supplement and food product that contains MITOPURE (UA) at specific levels after a controlled manufacturing process such as softgel capsules, gummies and powder. In the case of MITOPURE, which is a metabolite of a natural product present in food, one can only guarantee precise dosing levels by providing the bioactives in a specific formulation. Practically, it would not be possible to consume food products and receive the similar benefits of MITOPURE due to (1) seasonality (2) content level and (3) interpersonal variations of metabolism.
This clinical trial aims to comprehensively evaluate and compare the pharmacokinetic profiles of three distinct formulations of Urolithin A in healthy volunteers. Urolithin A, a metabolite derived from ellagic acid in foods, has garnered attention for its potential health benefits, including its association with improved muscle recovery and antioxidant properties. The formulations under investigation include a softgel capsule (Mitopure - Formulation A), B (DRC-UA), C (C-UA), D (DRC-UASD), E (C-UASD), F (DRC-UASDP), and G (C-UASDP).
The study adopts a randomized, open-label, single-dose, parallel-arm approach. The primary objective is to elucidate and compare the plasma pharmacokinetic parameters across the three Urolithin A formulations. By employing a rigorous methodology involving pharmacokinetic sampling at predetermined time points, this trial aims to provide detailed insights into the absorption, distribution, metabolism, and excretion of Urolithin A. Safety considerations are paramount, with secondary objectives focusing on assessing the safety and tolerability of the Urolithin A formulations. Adverse events and tolerability will be diligently monitored throughout the study, contributing to a comprehensive safety profile.
This study’s design as an open-label, single-dose, randomized trial aligns with the objective of characterizing the concentration-time profiles of Urolithin A formulation in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes.
Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female participants aged between 18 and 45 years (both inclusive); 2.Non-smoker subject or smoker of not more than 5 cigarettes a day; 3.Body Mass Index (BMI) between 18.50-30.00 kg/m2 inclusive; 4.Trial 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), individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator; 5.Normal ECG recording on a 12-lead ECG and/or chest X-ray (PA view) significant at the screening visit or considered not clinically significant (NCS) by investigators; 6.A negative alcohol breath test result at housing; 7.Trial participant able to communicate effectively, provide voluntary written informed consent and available for the entire study duration; 8.Trial participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee; 9.Ability to fast for at least 14.00 hours and consume standard meals; 10.Accept to refrain consuming certain foods and supplements at least two weeks before inclusion; 11.Female participants must have a negative urine pregnancy test prior to housing; 12.Trial participants that can provide adequate evidence of their identity; 13.The participants agree to refrain from consuming dietary supplements that could potentially impact either muscle or mitochondrial function or contain Urolithin A, such as resveratrol, pomegranate and ellagitannins, nicotinamide riboside, whey protein, leucine, iso-leucine, l-carnitine, creatinine, coenzyme Q10, vitamin A, niacin, folic acids, vitamin C, vitamin E and probiotic foods and supplements, during the 2 weeks before inclusion and throughout the study; 14.Females of childbearing potential agree to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and spermicidal agents during the study and 07 days after completion of the study; 15.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.
排除标准
- •1.known hypersensitivity to Urolithin A or related product or any component of intervention, presence or history of drug hypersensitivity, allergic disease or lactose intolerance; 2.Any history or presence of clinically significant medical condition, such as, but not limited to, cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, thyroid disease, adrenal dysfunction, or organic intracranial lesion; 3.Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study; 4.History or presence of alcoholism or drug abuse; 5.History or presence of gastric and/or duodenal ulceration; 6.History or presence of cancer; 7.Difficulty with donating blood; 8.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; 9.Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study; 10.Trial 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; 11.Trial participant consumed caffeine and/or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grapefruit juice and poppy-containing foods for at least 48.00 hours before initiation of the study and throughout the study; 12.Major illness during the 90 days before screening; 13.Participation in a drug research study within 90 days of screening; 14.Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL; 15.History or presence of easy bruising or bleeding; 16.Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study; 17.Females of childbearing potential with any one of the following reported and documented on the medical history: i.Postmenopausal with spontaneous amenorrhea for at least one year, or ii.Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii.Total hysterectomy and an absence of bleeding for at least 3 months; iv.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; 18.pregnant women and nursing mothers; 19.Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception like non-hormonal intrauterine devices, barrier methods, and spermicidal agents, Double Barrier method (Condom) during the study till 07 days after the completion of the study; 20.Male volunteers willing to donate sperm during the study till 07 days after the completion of the study.
结局指标
主要结局
Plasma Pharmacokinetics parameters of all three Urolithin A formulations
时间窗: PK blood samples will be collected at pre-dose [within 45 min before IP administration] and post-dose at 1hr, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 72hrs. (Total 8 Time points).
次要结局
- 1.Screening, pre-dose, and post-dose vital signs.(2.Chest X-ray ((P/A view) at screening.)