Trials / Completed
CompletedNCT06286033
Single and Multiple Ascending Dose Study and Food Effect Study for AG181
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AG-181 in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Agios Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AG-181 | AG-181 tablets |
| DRUG | Placebo | AG-181 matched-placebo tablets |
Timeline
- Start date
- 2024-02-20
- Primary completion
- 2025-10-09
- Completion
- 2025-10-09
- First posted
- 2024-02-29
- Last updated
- 2025-12-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06286033. Inclusion in this directory is not an endorsement.