Healthy AdultsNCT06853197
Bioavailability of Seven Mitopure Formulations
A study testing Mitopure (Urolithin A) in people with Healthy Adults, run by Amazentis SA at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Mitopure (Urolithin A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- 17 Mar 2025to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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;
- Ability to fast for at least 14.00 hours and consume standard meals;
- Accept to refrain consuming certain foods and supplements at least two weeks before inclusion;
- Female participants must have a negative urine pregnancy test prior to housing;
- Trial participants that can provide adequate evidence of their identity;
- 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;
- 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;
- 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.
Who cannot join
- 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;
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- 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;
- Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study;
- 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;
- 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;
- Major illness during the 90 days before screening;
- Participation in a drug research study 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 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;
- Pregnant women and nursing mothers;
- 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;
- Male volunteers willing to donate sperm during the study till 07 days after the completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Pharmacokinetic Profiles of Urolithin A Formulations in Healthy Volunteers: a Randomized, Open-label, Single-dose, Parallel-arm Study
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.
- Conditions
- Healthy Adults
- Being tested
- Mitopure (Urolithin A)
- Keywords
- Mitopure, Urolithin A, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitopure (Urolithin A)Dietary supplement
Mitopure (Urolithin A) is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Active comparator | Not described Receives: Dietary Supplement: Mitopure (Urolithin A) |
| Formulation B | Experimental | Not described Receives: Dietary Supplement: Mitopure (Urolithin A) |
| Formulation C | Experimental | Not described Receives: Dietary Supplement: Mitopure (Urolithin A) |
| Formulation D | Experimental | Not described Receives: Dietary Supplement: Mitopure (Urolithin A) |
| Formulation E | Experimental | Not described Receives: Dietary Supplement: Mitopure (Urolithin A) |
| Formulation F | Experimental | Not described Receives: Dietary Supplement: Mitopure (Urolithin A) |
| Formulation G | Experimental | Not described Receives: Dietary Supplement: Mitopure (Urolithin A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax)
Measured: 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).
Exposure to Urolithin A over time measured as area under the curve (AUC)
Measured: 72-hours.
Secondary outcomes (1)
Number of adverse events and serious adverse events throughout the study
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start17 Mar 2025
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mprex Healthcare Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Dr Ramshyam Agarwal, MD, Principal investigator, Lokmanya Medical Research Centre and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853197
- Sponsor's protocol ID
- MHC/CT/24-25/056
- Other IDs
- MHC/CT/24-25/056, Version No.:
- Status last verified
- May 2025
- First submitted
- 25 Feb 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Pharmacokinetic Profiles of Urolithin A Formulations in Healthy Volunteers: a Randomized, Open-label, Single-dose, Parallel-arm Study
- ClinicalTrials.gov ID
- NCT06853197
- Acronym / sponsor ID
- MHC/CT/24-25/056
- Conditions
- Healthy Adults
- Keywords
- Mitopure, Urolithin A, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- Mprex Healthcare Pvt. Ltd.
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Active comparator | Dietary Supplement: Mitopure (Urolithin A) |
| Formulation B | Experimental | Dietary Supplement: Mitopure (Urolithin A) |
| Formulation C | Experimental | Dietary Supplement: Mitopure (Urolithin A) |
| Formulation D | Experimental | Dietary Supplement: Mitopure (Urolithin A) |
| Formulation E | Experimental | Dietary Supplement: Mitopure (Urolithin A) |
| Formulation F | Experimental | Dietary Supplement: Mitopure (Urolithin A) |
| Formulation G | Experimental | Dietary Supplement: Mitopure (Urolithin A) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitopure (Urolithin A)Mitopure (Urolithin A) is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health | Dietary supplement | Formulation A, Formulation B, Formulation C, Formulation D, Formulation E, Formulation F, Formulation G |
Primary outcome
Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax)
Time frame: 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).
Exposure to Urolithin A over time measured as area under the curve (AUC)
Time frame: 72-hours.
1 secondary outcome
Number of adverse events and serious adverse events throughout the study
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Ramshyam Agarwal, MD principal investigator
Lokmanya Medical Research Centre and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitopure (Urolithin A) in people with Healthy Adults, run by Amazentis SA at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax) (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.