Bioavailability of Three Mitopure Formulations

A Comparative Pharmacokinetic Profiles of Three Urolithin A Formulations in Healthy Volunteers: A Randomized, Open-label, Single-dose, Parallel-arm Study

This study's design as an open-label, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of three 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 Overview

• Status: Not yet recruiting
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: Mitopure (Urolithin A)

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Gayatri Ganu, MD; Phone Number: +918554912644; Email: clinical@mprex.in

Study Locations

• India
  • Pune, India, 411033
    • Lokmanya Medical Research Centre and Hospital
    • Contact: Dr Ramshyam Agarwal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Formulation A: Mitopure (Urolithin A) soft-gel capsules; Mitopure (Urolithin A) two soft-gel capsules of 250 mg delivering total of 500 mg Urolithin A, to be taken with 240 mL water on an empty stomach, oral in overnight fasted participants.	Dietary supplement: Mitopure (Urolithin A); Mitopure (Urolithin A) is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
Experimental: Formulation B: Strawberry Mitopure (Urolithin A) Gummy; Strawberry Mitopure (Urolithin A) Gummy, two gummies containing 500 mg Urolithin A, to be taken with 240 mL water on an empty stomach, oral in overnight fasted participants.	Dietary supplement: Mitopure (Urolithin A); Mitopure (Urolithin A) is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health
Experimental: Formulation C: Pro Athletes Muscle recovery Mitopure (Urolithin A) powder; Pro Athletes Muscle recovery powder, Single dose of half a scoop of the powder containing 500 mg Mitopure (Urolithin A) to be taken with 240 mL milk on an empty stomach, oral in overnight fasted participants.	Dietary supplement: Mitopure (Urolithin A); Mitopure (Urolithin A) is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax)	Pharmacokinetic blood samples will be collected at pre-dose [within 45 min before product administration] and post-dose at 1-hours; 4-hours; 6-hours; 8-hours; 12-hours; 24-hours; and 72-hours. (Total 08 Time points).
Exposure to Urolithin A over time measured as area under the curve (AUC)	72-hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events and serious adverse events throughout the study.	72 hours

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: Mprex Healthcare Pvt. Ltd.
• Investigators: Principal Investigator: Dr Ramshyam Agarwal, MD, Lokmanya Medical Research Centre and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 9, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bioavailability; Urolithin A; Mitopure
• Other Study ID Numbers: MHC/CT/23-24/055; MHC/CT/23-24/055, Version No.: (Other Identifier: Mprex Healthcare Pvt. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No