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

NCT02655393 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-26

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Mitopure

Sponsors & Collaborators

  • Eurofins Optimed

    collaborator INDUSTRY

  • Amazentis SA

    lead INDUSTRY

Principal Investigators

  • Mathilde Latreille-Barbier, MD · Eurofins Optimed

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
61 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655393 on ClinicalTrials.gov