- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04098510
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
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.
Sponsor
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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