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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Agios Pharmaceuticals, Inc.
Study ID
NCT07241234
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • AG-181 — DRUG
    AG-181 film-coated tablets

Study Details

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

Key Dates

Start date
Apr 17, 2026
Status verified
May 2026
Primary completion
Jan 17, 2028
Completion
Jan 17, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: AG-181
    Subjects will receive AG-181 from Day 1 to Day 28.
  • Experimental: Cohort 2 (Optional Cohort): AG-181
    Subjects will receive AG-181.

Primary Outcome Measure

Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to the Study Drug [ Time Frame: Up to Day 42 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical Center (UTSW)DallasTexas75390-

Find similar trials in Dallas, TX

By research site
University of Texas Southwestern Medical Center (UTSW)· Dallas, TX

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