UnknownPhase 3

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

United States7 participantsStarted 2021-10-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: * Male or non-pregnant, non-lactating female subject with a CG diagnosis * Previous participation in Study AT-007-1001 Part D and/or Part D Extension * No other significant health problems which preclude participation Exclusion Criteria: * Concomitant use of certain medications or over-the-counter therapies * Discontinuation from Study AT-007-1001 Part D and/or Part D Extension due an adverse event

What they're measuring

To evaluate the long-term safety of 12-month oral administration of AT-007 in adult subjects with CG as assessed by adverse events.

Timeframe: 12 months

To evaluate the long-term safety of 12-month oral administration of AT-007 in adult subjects with CG as assessed by clinical laboratory test results.

Timeframe: 12 months

To evaluate the long-term safety of 12-month oral administration of AT-007 in adult subjects with CG as assessed by physical exam parameters.

Timeframe: 12 months

Trial details

NCT IDNCT05418829

SponsorApplied Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11

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