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Not Yet RecruitingNCT07241234

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria

A Phase 1b, Open-label, Multicenter, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of AG-181 in Subjects With Phenylketonuria

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Agios Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years – 69 Years
Healthy volunteers
Not accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of AG-181 in subjects with Phenylketonuria (PKU).

Conditions

Interventions

TypeNameDescription
DRUGAG-181AG-181 film-coated tablets

Timeline

Start date
2026-03-01
Primary completion
2028-01-17
Completion
2028-01-17
First posted
2025-11-21
Last updated
2026-03-30

Regulatory

Source: ClinicalTrials.gov record NCT07241234. Inclusion in this directory is not an endorsement.

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonu (NCT07241234) · Clinical Trials Directory