Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06362018
Other study ID # MHC/CT/23-24/055
Secondary ID MHC/CT/23-24/055
Status Recruiting
Phase N/A
First received
Last updated
Start date May 7, 2024
Est. completion date July 31, 2024

Study information

Verified date May 2024
Source Amazentis SA
Contact Dr Gayatri Ganu, MD
Phone +918554912644
Email clinical@mprex.in
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
India Lokmanya Medical Research Centre and Hospital Pune

Sponsors (2)

Lead Sponsor Collaborator
Amazentis SA Mprex Healthcare Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Primary Exposure to Urolithin A over time measured as area under the curve (AUC) 72-hours
Secondary Number of adverse events and serious adverse events throughout the study. 72 hours
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04677920 - The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology N/A
Active, not recruiting NCT03312920 - Investigating Memory Retrieval Improvement in Healthy Subjects N/A
Completed NCT03309072 - Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task N/A
Completed NCT03289832 - Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin N/A
Enrolling by invitation NCT06133530 - Human Milk Oligosaccharides (HMOs) and Gut Microbiota, Immune System in Antarctica N/A
Completed NCT05141903 - Dietary Supplement With and Without a Probiotic and/or Antibiotic
Completed NCT01689259 - Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults Phase 1
Completed NCT01187875 - Resistant Starch and Satiety Phase 0
Completed NCT03312699 - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Phase 1
Completed NCT03319134 - Investigating the Neural Correlates in Memory Retrieval After HD-tDCS N/A
Recruiting NCT04104360 - Galacto-oligosaccharides and Intestinal Activity N/A
Completed NCT03228693 - Gene Expression and Biomarker Profiling of Keloid Skin N/A
Completed NCT04206293 - A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers N/A
Completed NCT04146532 - Aspirin Effects on Emotional Reactions Early Phase 1
Recruiting NCT06011018 - Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke N/A
Completed NCT05093205 - STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS Phase 1
Completed NCT04596709 - Investigation of Blood Glucose and Insulin Response After Intake of Vitalose N/A
Completed NCT04272450 - Respiratory Muscle Strength in Different Age Groups
Completed NCT02044679 - Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions N/A
Completed NCT01402973 - Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products N/A