Bioavailability of Five Mitopure Formulations

NCT06362018 | Completed

• 2 other identifiers: MHC/CT/23-24/055MHC/CT/23-24/055, Version No.:
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Mitopure; Urolithin A; Bioavailability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of adverse events and serious adverse events throughout the study.

  72 hours

Study Arms (5)

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)

Interventions

Mitopure (Urolithin A) DIETARY_SUPPLEMENT

Mitopure (Urolithin A) is gut microbiome derived postbiotic that has been shown to improve muscle and mitochondrial health

Formulation A; Formulation B; Formulation C; Formulation D; Formulation E

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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;
• Female participants must have a negative urine pregnancy test prior to housing; 12.Trial participants that can provide adequate evidence of their identity;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Amazentis SA: lead
• Mprex Healthcare Pvt. Ltd.: collaborator

Study Sites (1)

Lokmanya Medical Research Centre and Hospital

Pune, 411033, India

Location

MeSH Terms

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Study Officials

• Dr Ramshyam Agarwal, MD

  Lokmanya Medical Research Centre and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 12, 2024
• Study Start: May 7, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)