drugset / Trial / NCT03960502
A Safety and Pharmacokinetic Study of AG-881 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881
NaSingle-groupOpen-labelBasic science
Summary
The purpose of this Phase I, open-label study is to evaluate the absorption, distribution, metabolism, excretion, absolute bioavailability, and to characterize the metabolites of AG-881 in healthy male participants following administration of a single oral dose of \[14C\] AG-881 and a concomitant intravenous microdose of \[13C315N3\] AG-881.
Timeline
- Start
- 2019-05-16
- Primary completion
- 2019-09-07
- Completion
- 2019-09-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vorasidenib | Small molecule | 100 ug | Oral |
| Subject | Vorasidenib | Small molecule | 50 mg | Oral |
Indications
No indication recorded.