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OpenTrials
Completed

NCT Number: NCT05028764

Determine Range of Tissue Frataxin Concentrations and Other Potential Biomarkers

To examine range of tissue frataxin (FXN) concentrations, specific ribonucleic acids, other proteins and specialized lipids in the buccal cells, blood, and skin cells of normal healthy volunteers without Friedreich's ataxia (FRDA).

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Key information

About this study

Primary Objective: To examine the range of tissue frataxin (FXN) concentrations in the buccal cells, blood, and skin cells of normal healthy volunteers without FRDA.

Secondary Objective: To examine the range of specific ribonucleic acids (RNAs), other proteins, and specialized lipids in the buccal cells, blood, and skin cells of normal healthy volunteers without FRDA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is a healthy male or female,18-50 years of age
  • Subject has a body mass index (BMI) ≥18.0 and ≤32.0 as of the screening visit.
  • Subject is racially Caucasian, Asian, Native Hawaiian, or Native American.

Exclusion criteria

  • Subject used erythropoietin, etravirine, or gamma interferon within 3 months prior to the Day 1 (assessment) visit.
  • Subject has a chronic condition that requires ongoing prescription drug treatment.
  • Subject use of any statin medications within 3 months before the Day 1 (assessment) visit.
  • Subject use of any lipid-lowering agents, other than statins, within 6 weeks before the Day 1 (assessments) visit.
  • Subject is racially black or African American.
  • Pregnant or breast-feeding female subjects.
  • Subject has a known history of drug or alcohol abuse or current suspected drug or alcohol abuse.
  • Subject is positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis A virus (HAV).
  • Subject has any condition, disease, or situation, that in the opinion of the principal investigator (PI), could confound the results of the study or put the subject at undue risk, making participation inadvisable.

Treatment and study plan

Buccal Swabs, Blood Draws and Skin Punch Biopsy

Diagnostic Test

Buccal Swabs - FXN and specific RNA markers; Blood Draws - Lipid panel, Protein Marker Analysis and Gene RNA Analysis; Skin Punch Biopsy - Protein Markers

Primary outcomes

  1. Examine tissue frataxin concentrations in buccal cells, blood and skin cells

    Time frame: 1 day

    Range of tissue frataxin levels in buccal cells, blood and skin cells

Secondary outcomes

  1. Examine specific ribonucleic acids (RNAs), other proteins, and specialized lipids in buccal cells and blood

    Time frame: 1 day

    Range of specific ribonucleic acids (RNAs), other proteins, and specialized lipids in buccal cells and blood

Sponsors and collaborators

Lead sponsor

Larimar Therapeutics, Inc.

Industry

Collaborators

  • Clinilabs, Inc.

Registry information

Official study title

A Study to Determine the Range of Tissue Frataxin Concentrations and Other Potential Biomarkers for Friedreich's Ataxia in Normal Healthy Volunteers

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2021
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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