Concentration of MitoQ in Human Skeletal Muscle (MitoQ/muscle)

September 20, 2019 updated by: Morten Hostrup, PhD, University of Copenhagen

Concentration of Mitoquinone Mesylate in Skeletal Muscle After a Single Oral Dose of MitoQ

The purpose of this study is to determine mitoquinone mesylate concentration levels in skeletal muscle samples obtained after intake of an acute oral dose of MitoQ.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark
        • Recruiting
        • August Krogh Building
        • Principal Investigator:
          • Matteo Fiorenza, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy,
  • Male
  • 18-40 years of age

Exclusion Criteria:

  • Previous use of MitoQ or CoQ-10 within 30 days of screening appointment
  • Ongoing use of MitoQ
  • Smoking
  • Ongoing treatment with medications
  • Disease deemed by the MD to infer a risk to participate in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MitoQ
Subjects ingest 160 mg of MitoQ
Subjects ingest 8x20 mg MitoQ capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mitoquinone mesylate concentration
Time Frame: Before oral administration of MitoQ
Concentration of mitoquinone mesylate in skeletal muscle
Before oral administration of MitoQ
Muscle mitoquinone mesylate concentration
Time Frame: 1 hours after oral administration of MitoQ
Concentration of mitoquinone mesylate in skeletal muscle
1 hours after oral administration of MitoQ
Muscle mitoquinone mesylate concentration
Time Frame: 3 hours after oral administration of MitoQ
Concentration of mitoquinone mesylate in skeletal muscle
3 hours after oral administration of MitoQ
Muscle mitoquinone mesylate concentration
Time Frame: 5 hours after oral administration of MitoQ
Concentration of mitoquinone mesylate in skeletal muscle
5 hours after oral administration of MitoQ

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood mitoquinone mesylate concentration
Time Frame: Before as well as 0.5, 1, 1.5, 2, 3, 4 and 5 hours after oral administration of MitoQ
Concentration of mitoquinone mesylate in venous blood
Before as well as 0.5, 1, 1.5, 2, 3, 4 and 5 hours after oral administration of MitoQ

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2019

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • MitoQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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