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

NCT02655393 | Completed Phase 1

• 2 other identifiers: 15.02.AMZOP095615.AMA - OP095715.AMA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Mitochondrial Dysfunction; Muscle Function

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events

  6 weeks

Secondary Outcomes (8)

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

  6 weeks

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

  6 weeks

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

  6 weeks

• Cmax of AMAZ-02 and its metabolites in urine

  6 weeks

• AUC of AMAZ-02 and its metabolites in urine

  6 weeks

Study Arms (9)

Mitopure 250 mg single dose

EXPERIMENTAL

single dose of Mitopure soft gel capsules at 250 mg dose, n=8 subjects (6 Active, 2 Placebo)

Dietary Supplement: Mitopure

Mitopure 500 mg single dose

EXPERIMENTAL

single dose of Mitopure soft gel capsules at 500 mg dose, n=8 subjects (6 Active, 2 Placebo)

Dietary Supplement: Mitopure

Mitopure 1000 mg single dose

EXPERIMENTAL

single dose of Mitopure soft gel capsules at 1000 mg dose, n=8 subjects (6 Active, 2 Placebo)

Dietary Supplement: Mitopure

Mitopure 2000 mg single dose

EXPERIMENTAL

single dose of Mitopure soft gel capsules at 2000 mg dose, n=8 subjects (6 Active, 2 Placebo)

Dietary Supplement: Mitopure

Mitopure 500 mg single dose-Food Effect

EXPERIMENTAL

single dose of Mitopure admixed in yoghurt at 500 mg dose, n=8 subjects (6 Active, 2 Placebo)

Dietary Supplement: Mitopure

Mitopure 1000 mg single dose-Food Effect

EXPERIMENTAL

single dose of Mitopure admixed in yoghurt at 1000 mg dose, n=8 subjects (6 Active, 2 Placebo)

Dietary Supplement: Mitopure

Mitopure 250 mg multiple dose

EXPERIMENTAL

Repeated 28 day dosing of Mitopure soft gel capsules at 250 mg dose, n=12 subjects (9 Active, 3 Placebo)

Dietary Supplement: Mitopure

Mitopure 500 mg multiple 28 day dose

EXPERIMENTAL

Repeated 28 day dosing of Mitopure soft gel capsules at 500 mg dose, n=12 subjects (9 Active, 3 Placebo)

Dietary Supplement: Mitopure

Mitopure 1000 mg multiple 28 day dose

EXPERIMENTAL

Repeated 28 day dosing of Mitopure soft gel capsules at 1000 mg dose, n=12 subjects (9 Active, 3 Placebo)

Dietary Supplement: Mitopure

Interventions

Mitopure DIETARY_SUPPLEMENT

Mitopure 1000 mg multiple 28 day dose; Mitopure 1000 mg single dose; Mitopure 1000 mg single dose-Food Effect; Mitopure 2000 mg single dose; Mitopure 250 mg multiple dose; Mitopure 250 mg single dose; Mitopure 500 mg multiple 28 day dose; Mitopure 500 mg single dose; Mitopure 500 mg single dose-Food Effect

Eligibility Criteria

• Age: 61 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• mmHg ≤ Systolic Blood Pressure (SBP) ≤ 160 mmHg,
• mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 95 mmHg,
• bpm \< HR \< 80 bpm,
• Or considered NCs by investigators;
• Normal ECG recording on a 12-lead ECG at the screening visit:
• \< 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Amazentis SA: lead
• Eurofins Optimed: collaborator

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

Related Publications (1)

• 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.

  PMID: 32694802 BACKGROUND

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mathilde Latreille-Barbier, MD

  Eurofins Optimed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 14, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

FR (1)