Cerebrospinal Fluid Kinetics of Urolithin A
ConditionHealthy Adult
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmazentis SA
About this trial
The purpose of this study is to determine the impact of Mitopure® consumption on urolithin A (UA) kinetics in cerebral spinal fluid (CSF).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Mitopure
- Placebo
Treatment groups
40 Participants
are divided into 5 treatment groupsSponsors and collaborators
Amazentis SA
Lead sponsor
Mprex Healthcare Pvt. Ltd.
Collaborator
Source ClinicalTrials.gov