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AgingPhase 1NCT02655393

A Single and Multiple Dose Study of AMAZ-02 to Evaluate Safety and Pharmacokinetics in Elderly Subjects

A Phase 1 study testing Mitopure in people with Aging and Mitochondrial Dysfunction, run by Amazentis SA at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Part A: The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly male and female volunteers. Each subject will be randomized for two subsequent doses in three cohorts. Read more about this study

Who is it for?
Ages 61 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Mitochondrial Dysfunction, Muscle Function
What is being tested?
Mitopure
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
Jan 2016to Dec 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 61 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male and female elderly subject, aged between 61 and 85 years inclusive;
  • Non-smoker subject or smoker of not more than 5 cigarettes a day;
  • Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive;
  • Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination);
  • Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position:
  • 95 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 160 mmHg,
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  • 50 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 95 mmHg,
  • 50 bpm < HR < 80 bpm,
  • Or considered NCs by investigators;
  • Normal ECG recording on a 12-lead ECG at the screening visit:
  • 120 < PR < 220 ms,
  • QRS < 120 ms,
  • QTcf < 430 ms for male and < 450 ms for female,
  • No sign of any trouble of sinusal automatism,
  • Or considered NCS by investigators;
  • Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator;
  • Normal dietary habits;
  • Demonstrate sedentary behaviour defined as having an activity category of 1 as assessed by the International Physical Activity Questionnaire (IPAQ). Activity level is < 600 MET (metabolic equivalent unit - minutes per week and limited to light intensity activities.
  • Accept to refrain consuming certain foods and supplements at least two weeks before inclusion.
  • Comprehension of the nature and purpose of the study and ability to communicate in person and by telephone in a manner that allows all protocol procedures to be carried out safety and reliably in the opinion of the investigative site staff
  • Ability to take up to 8 capsules of study medication
  • Signing a written informed consent prior to selection;
  • Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Who cannot join

  • Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease;
  • Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
  • Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position;
  • Blood donation (including in the frame of a clinical trial) within 2 months before administration;
  • General anaesthesia within 3 months before administration;
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
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  • Lactose intolerance, milk protein or soy allergy.
  • Inability to abstain from intensive muscular effort;
  • No possibility of contact in case of emergency;
  • Use of any of the prohibited medications as detailed in the concomitant medication section
  • History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
  • Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day);
  • Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
  • Positive results of screening for drugs of abuse;
  • Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
  • Exclusion period of a previous study;
  • Administrative or legal supervision;
  • Subjects should not have participated in previous clinical trials in the last 3 months and received compensation beyond a certain approved and predefined limit

Trial locations and contacts

1 site in 1 country.

France1 site

  • Eurofins Optimed

    Gières, 38610

Other trials in France

About this study

Official title: A Single (Part A) and Multiple (Part B) Dose Study of AMAZ-02, a Food Derived Ingredient to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Profile in Healthy Elderly Subjects

Part A:

The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly male and female volunteers. Each subject will be randomized for two subsequent doses in three cohorts.

Part B:

The study is a double-blind, randomized, multiple ascending doses study in 36 healthy elderly male and female volunteers. Subjects will be randomized to receive study product or placebo for 28 days.

Read the detailed description

Part A: Single Ascending Dose study of AMAZ-02 with 3 cohorts (each cohort n=8 subjects, total n=24 subjects). Cohorts undergo two periods of single dose intervention separated by 3 week washout. Adverse events, clinical biochemistry for safety assessment and plasma and urine collected for pharmacokinetic measurement for parent and metabolite levels in circulation.

Part B: Multiple Ascending Dose study with 3 cohorts (each cohort n=12 subjects, total n=36 subjects). 28 day administration with AMAZ-02 for safety, PK and PD assessment.

Being tested
Mitopure
Medical subject headings
Mitochondrial Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MitopureDietary supplement

Study groups in NCT02655393
Study groupRoleWhat they receive
Mitopure 250 mg single doseExperimentalsingle dose of Mitopure soft gel capsules at 250 mg dose, n=8 subjects (6 Active, 2 Placebo)
Receives: Dietary Supplement: Mitopure
Mitopure 500 mg single doseExperimentalsingle dose of Mitopure soft gel capsules at 500 mg dose, n=8 subjects (6 Active, 2 Placebo)
Receives: Dietary Supplement: Mitopure
Mitopure 1000 mg single doseExperimentalsingle dose of Mitopure soft gel capsules at 1000 mg dose, n=8 subjects (6 Active, 2 Placebo)
Receives: Dietary Supplement: Mitopure
Mitopure 2000 mg single doseExperimentalsingle dose of Mitopure soft gel capsules at 2000 mg dose, n=8 subjects (6 Active, 2 Placebo)
Receives: Dietary Supplement: Mitopure
Mitopure 500 mg single dose-Food EffectExperimentalsingle dose of Mitopure admixed in yoghurt at 500 mg dose, n=8 subjects (6 Active, 2 Placebo)
Receives: Dietary Supplement: Mitopure
Mitopure 1000 mg single dose-Food EffectExperimentalsingle dose of Mitopure admixed in yoghurt at 1000 mg dose, n=8 subjects (6 Active, 2 Placebo)
Receives: Dietary Supplement: Mitopure
Mitopure 250 mg multiple doseExperimentalRepeated 28 day dosing of Mitopure soft gel capsules at 250 mg dose, n=12 subjects (9 Active, 3 Placebo)
Receives: Dietary Supplement: Mitopure
Mitopure 500 mg multiple 28 day doseExperimentalRepeated 28 day dosing of Mitopure soft gel capsules at 500 mg dose, n=12 subjects (9 Active, 3 Placebo)
Receives: Dietary Supplement: Mitopure
Mitopure 1000 mg multiple 28 day doseExperimentalRepeated 28 day dosing of Mitopure soft gel capsules at 1000 mg dose, n=12 subjects (9 Active, 3 Placebo)
Receives: Dietary Supplement: Mitopure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events

    Measured: 6 weeks

Secondary outcomes (8)

  1. Plasma concentrations of AMAZ-02 and its metabolites over time and maximal plasma concentration (Cmax)

    Measured: 6 weeks

  2. Exposure to AMAZ-02 measured as area under the curve (AUC)

    Measured: 6 weeks

  3. Half-live (t 1/2) of AMAZ-02 and its metabolites

    Measured: 6 weeks

  4. Cmax of AMAZ-02 and its metabolites in urine

    Measured: 6 weeks

  5. AUC of AMAZ-02 and its metabolites in urine

    Measured: 6 weeks

  6. Gene expression for mitochondrial biomarkers in PBMC

    Measured: 6 weeks

  7. Gene expression for mitochondrial biomarkers in muscle tissue

    Measured: 6 weeks

  8. Blood Lipid Profile

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionSep 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655393
Sponsor's protocol ID
15.02.AMZ
Other IDs
OP095615.AMA - OP095715.AMA
Status last verified
Aug 2022
First submitted
8 Jan 2016
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
No

Publications

  • Andreux PA, Blanco-Bose W, Ryu D, Burdet F, Ibberson M, Aebischer P, Auwerx J, Singh A, Rinsch C. The mitophagy activator urolithin A is safe and induces a molecular signature of improved mitochondrial and cellular health in humans. Nat Metab. 2019 Jun;1(6):595-603. doi: 10.1038/s42255-019-0073-4. Epub 2019 Jun 14.

    PubMed 32694802

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mitopure in people with Aging and Mitochondrial Dysfunction, run by Amazentis SA at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with adverse events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655393, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.

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