drugset / Trial / NCT05418829

AT-007 in Adult Subjects With Classic Galactosemia (CG)

NCT05418829 ↗

Phase 3 Unknown 7 enrolled Applied Therapeutics, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This study is a 12-month open-label extension (OLE) study of AT-007 in adult subjects with CG who previously participated in Study AT-007-1001 Part D and/or Part D Extension. The study is designed to assess the long-term safety of AT-007 in subjects with CG as well as the pharmacodynamics (PD) (inhibition of galactitol) and PK of AT-007. The effect of 12-month treatment with AT-007 on the levels of galactose and other galactose metabolites in subjects with CG will also be evaluated.

Timeline

Start
2021-10-01
Primary completion
2022-11
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Govorestat Small molecule 20 mg/kg Oral

Indications