Single and Multiple Ascending Dose Study and Food Effect Study for AG181
← catalyst calendarSponsored by Agios Pharmaceuticals, Inc. (industry) · AGIO — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
88actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-02-20 | actual | When the study began enrolling |
| Primary completion | 2025-10-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-09 | actual | The whole study's end, after follow-up |
| First posted | 2024-02-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Interventions
- Drug: AG-181
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFSAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug
measured Up to Day 7
MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug
measured Up to Day 26
Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181
measured Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Area Under the Concentration-time Curve up to the Last Quantifiable Concentration (AUC0-last) of AG-181
measured Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AG-181
measured Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181
measured Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181
measured Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181
measured Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Apparent Oral Clearance (CL/F) of AG-181
measured Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
measured Predose and multiple time points postdose from Day 1 to Day 4
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