CompletedNot Applicable

Bioavailability of Five Mitopure Formulations

India60 participantsStarted 2024-05-07

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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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;
✓. 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

What they're measuring

Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 72-hours

Trial details

NCT IDNCT06362018

SponsorAmazentis SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-14

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