Bioavailability of Seven Mitopure Formulations (NCT06853197) | Clinical Trial Compass
CompletedNot Applicable
Bioavailability of Seven Mitopure Formulations
India84 participantsStarted 2025-03-17
Plain-language summary
This study's design as an open-label, single-period, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of seven Urolithin A (Mitopure) formulations 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 the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male and female participants aged between 18 and 45 years (both inclusive);
. Non-smoker subject or smoker of not more than 5 cigarettes a day;
. Body Mass Index (BMI) between 18.50-30.00 kg/m2 inclusive;
. 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;
. 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;
. A negative alcohol breath test result at housing;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax)
Timeframe: Pre-dose [within 45 minutes before IP administration] and post-dose at 1 hour, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 72 hours. (Total 8 Time points).
2
Exposure to Urolithin A over time measured as area under the curve (AUC)
. Trial participant able to communicate effectively, provide voluntary written informed consent and available for the entire study duration;
. Trial participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee;
Exclusion criteria
. Known hypersensitivity to Urolithin A or related product or any component of intervention, presence or history of drug hypersensitivity, allergic disease or lactose intolerance;
. 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;
. 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 gastric and/or duodenal ulceration;
. History or presence of cancer;
. Difficulty with donating blood;
. 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;