Clinical Trial

PheCheck™ Validation Study

Name: PheCheck™ Validation Study — clinical trial record (NCT07551921)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

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Summary

The goal of this observational study is to evaluate the performance of the PheCheck™ test for the rapid detection of phenylalanine (Phe) from a fingerstick sample, in patients 1 year or older with phenylketonuria (PKU) or hyperphenylalaninemia. The main objective is comparing the concentration of phenylalanine (Phe) in capillary blood with the reference method (DBS).

Trial Details

NCT Number	NCT07551921
Lead Sponsor	Aptatek BioSciences, Inc
Conditions	Phenylketonuria (PKU) and Hyperphenylalaninemia
Enrollment	60 participants
Start Date	2026-05-20
Primary Completion	2026-12-15 (estimated)
Study Completion	2027-03-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-27