Trials / Completed
CompletedNCT02218346
Food Effect Study of AG-221 in Healthy Male Subjects
A Phase 1, Two-Way Crossover Study to Assess the Pharmacokinetics and Safety of a Single Dose of AG-221 in Healthy Male Subjects When Administered Under Fed and Fasted Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Agios Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 56 Years
- Healthy volunteers
- Accepted
Summary
AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer treatment. Administration of oral drugs with food may change the absorption of drugs, and it is therefore useful to characterize the effect of food early in drug development.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AG221 | AG221 in fed and fasted conditions |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2014-12-01
- Completion
- 2015-03-01
- First posted
- 2014-08-18
- Last updated
- 2015-12-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02218346. Inclusion in this directory is not an endorsement.