CompletedNot Applicable

Determine Range of Tissue Frataxin Concentrations and Other Potential Biomarkers

United States60 participantsStarted 2021-08-04

Plain-language summary

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).

Who can participate

Age range18 Years – 50 Years

SexALL

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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).

What they're measuring

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

Timeframe: 1 day

Trial details

NCT IDNCT05028764

SponsorLarimar Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-02-04

View on ClinicalTrials.gov More Friedreich Ataxia trials