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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05028764
Other study ID # CLIN-1601-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 4, 2021
Est. completion date February 4, 2022

Study information

Verified date February 2022
Source Larimar Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 4, 2022
Est. primary completion date February 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: 1. Subject is a healthy male or female,18-50 years of age 2. Subject has a body mass index (BMI) =18.0 and =32.0 as of the screening visit. 3. Subject is racially Caucasian, Asian, Native Hawaiian, or Native American. Exclusion Criteria: 1. Subject used erythropoietin, etravirine, or gamma interferon within 3 months prior to the Day 1 (assessment) visit. 2. Subject has a chronic condition that requires ongoing prescription drug treatment. 3. Subject use of any statin medications within 3 months before the Day 1 (assessment) visit. 4. Subject use of any lipid-lowering agents, other than statins, within 6 weeks before the Day 1 (assessments) visit. 5. Subject is racially black or African American. 6. Pregnant or breast-feeding female subjects. 7. Subject has a known history of drug or alcohol abuse or current suspected drug or alcohol abuse. 8. Subject is positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis A virus (HAV). 9. 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Clinilabs Drug Development Corporation Eatontown New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Larimar Therapeutics, Inc. Clinilabs, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Deutsch EC, Santani AB, Perlman SL, Farmer JM, Stolle CA, Marusich MF, Lynch DR. A rapid, noninvasive immunoassay for frataxin: utility in assessment of Friedreich ataxia. Mol Genet Metab. 2010 Oct-Nov;101(2-3):238-45. doi: 10.1016/j.ymgme.2010.07.001. Epub 2010 Jul 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Examine tissue frataxin concentrations in buccal cells, blood and skin cells Range of tissue frataxin levels in buccal cells, blood and skin cells 1 day
Secondary Examine specific ribonucleic acids (RNAs), other proteins, and specialized lipids in buccal cells and blood Range of specific ribonucleic acids (RNAs), other proteins, and specialized lipids in buccal cells and blood 1 day
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