Radiolabeled Study of AG-221 in Healthy Male Subjects.

Summary

This is a single-center, 2-part, open-label study to evaluate the metabolism and excretion and absolute bioavailability of \[14C\]-AG-221 in healthy male subjects. It is planned for 14 subjects to be enrolled; each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be collected in Part 1 for analyses. Blood samples will be collected in Part 2. Subjects can only participate in either Part 1 or Part 2.

Timeline

Start

2015-05-14

Primary completion

2015-07-21

Completion

2015-07-21

Publications

• Wang X, Chen J, Reyes J, Zhou S, Palmisano M, Li Y. A Phase 1, Open-Label Study in Healthy Subjects to Evaluate the Absolute Bioavailability of AG-221 by a Microtracer Approach. Oncol Ther. 2020 Jun;8(1):91-102. doi: 10.1007/s40487-019-0097-7. Epub 2019 Jul 19.

Drugs

Indications

No indication recorded.