NCT02443168

Radiolabeled Study of AG-221 in Healthy Male Subjects.

Completed Phase 1 Last updated 30 October 2018

What this trial tests

Phase 1 trial testing AG-221 in Healthy Volunteers in 8 participants. Completed in 21 July 2015.

Timeline

14 May 2015

Primary endpoint
21 July 2015

21 July 2015

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	8
Start date	14 May 2015
Primary completion	21 July 2015
Estimated completion	21 July 2015

Drugs / interventions tested

• AG-221 — full drug profile →
• 14C AG-221

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enasidenib in the treatment of relapsed/refractory acute myeloid leukemia: an evidence-based review of its place in therapy.
   Galkin M, Jonas BA. · · 2019 · cited 16× · PMID 31118877 · DOI 10.2147/ce.s172912
2. A Phase 1, Open-Label Study in Healthy Subjects to Evaluate the Absolute Bioavailability of AG-221 by a Microtracer Approach.
   Wang X, Chen J, Reyes J, Zhou S, et al · · 2020 · cited 5× · PMID 32700065 · DOI 10.1007/s40487-019-0097-7