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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655393
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
Eurofins Optimed
Information provided by (Responsible Party):
Amazentis SA

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Aging Mitochondrial Dysfunction Muscle Function Dietary Supplement: AMAZ-02 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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
Study Start Date : January 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: AMAZ-02 250 mg single dose
single dose of AMAZ-02 soft gel capsules at 250 mg dose, n=8 subjects (6 Active, 2 Placebo)
Dietary Supplement: AMAZ-02
Experimental: AMAZ-02 500 mg single dose
single dose of AMAZ-02 soft gel capsules at 500 mg dose, n=8 subjects (6 Active, 2 Placebo)
Dietary Supplement: AMAZ-02
Experimental: AMAZ-02 1000 mg single dose
single dose of AMAZ-02 soft gel capsules at 1000 mg dose, n=8 subjects (6 Active, 2 Placebo)
Dietary Supplement: AMAZ-02
Experimental: AMAZ-02 2000 mg single dose
single dose of AMAZ-02 soft gel capsules at 2000 mg dose, n=8 subjects (6 Active, 2 Placebo)
Dietary Supplement: AMAZ-02
Experimental: AMAZ-02 500 mg single dose-Food Effect
single dose of AMAZ-02 admixed in yoghurt at 500 mg dose, n=8 subjects (6 Active, 2 Placebo)
Dietary Supplement: AMAZ-02
Experimental: AMAZ-02 1000 mg single dose-Food Effect
single dose of AMAZ-02 admixed in yoghurt at 1000 mg dose, n=8 subjects (6 Active, 2 Placebo)
Dietary Supplement: AMAZ-02
Experimental: AMAZ-02 250 mg multiple dose
Repeated 28 day dosing of AMAZ-02 soft gel capsules at 250 mg dose, n=12 subjects (9 Active, 3 Placebo)
Dietary Supplement: AMAZ-02
Experimental: AMAZ-02 500 mg multiple 28 day dose
Repeated 28 day dosing of AMAZ-02 soft gel capsules at 500 mg dose, n=12 subjects (9 Active, 3 Placebo)
Dietary Supplement: AMAZ-02
Experimental: AMAZ-02 1000 mg multiple 28 day dose
Repeated 28 day dosing of AMAZ-02 soft gel capsules at 1000 mg dose, n=12 subjects (9 Active, 3 Placebo)
Dietary Supplement: AMAZ-02



Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Plasma concentrations of AMAZ-02 and its metabolites over time and maximal plasma concentration (Cmax) [ Time Frame: 6 weeks ]
  2. Exposure to AMAZ-02 measured as area under the curve (AUC) [ Time Frame: 6 weeks ]
  3. Half-live (t 1/2) of AMAZ-02 and its metabolites [ Time Frame: 6 weeks ]
  4. Cmax of AMAZ-02 and its metabolites in urine [ Time Frame: 6 weeks ]
  5. AUC of AMAZ-02 and its metabolites in urine [ Time Frame: 6 weeks ]
  6. Gene expression for mitochondrial biomarkers in PBMC [ Time Frame: 6 weeks ]
  7. Gene expression for mitochondrial biomarkers in muscle tissue [ Time Frame: 6 weeks ]
  8. Blood Lipid Profile [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   61 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female elderly subject, aged between 61 and 85 years inclusive;
  2. Non-smoker subject or smoker of not more than 5 cigarettes a day;
  3. Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive;
  4. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination);
  5. 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,
    • 50 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 95 mmHg,
    • 50 bpm < HR < 80 bpm,
    • Or considered NCs by investigators;
  6. 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;
  7. 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;
  8. Normal dietary habits;
  9. 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.
  10. Accept to refrain consuming certain foods and supplements at least two weeks before inclusion.
  11. 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
  12. Ability to take up to 8 capsules of study medication
  13. Signing a written informed consent prior to selection;
  14. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria:

  1. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease;
  2. Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
  3. 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;
  4. Blood donation (including in the frame of a clinical trial) within 2 months before administration;
  5. General anaesthesia within 3 months before administration;
  6. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
  7. Lactose intolerance, milk protein or soy allergy.
  8. Inability to abstain from intensive muscular effort;
  9. No possibility of contact in case of emergency;
  10. Use of any of the prohibited medications as detailed in the concomitant medication section
  11. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
  12. Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day);
  13. 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;
  14. Positive results of screening for drugs of abuse;
  15. 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;
  16. Exclusion period of a previous study;
  17. Administrative or legal supervision;
  18. Subjects should not have participated in previous clinical trials in the last 3 months and received compensation beyond a certain approved and predefined limit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655393


Locations
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France
Eurofins Optimed
Gières, France, 38610
Sponsors and Collaborators
Amazentis SA
Eurofins Optimed
Investigators
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Principal Investigator: Mathilde Latreille-Barbier, MD Eurofins Optimed

Layout table for additonal information
Responsible Party: Amazentis SA
ClinicalTrials.gov Identifier: NCT02655393    
Other Study ID Numbers: 15.02.AMZ
OP095615.AMA - OP095715.AMA ( Other Identifier: Amazentis SA )
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017