NCT02489513

Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120

A Phase 1, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120 Following Single Oral Dose Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study is designed to characterize the absorption, metabolism, and excretion of AG-120 using radiolabeled drug in healthy adult male subjects to support its further development and registration.

Detailed description

This will be a single-center, open-label, study in healthy adult males. Each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up period. Subjects who have met all inclusion criteria and none of the exclusion criteria at screening will return to the clinical site on Day -1 for baseline assessments. Following a 10 hour overnight fast, subjects will receive a single 500mg dose of AG-120 suspension containing a microtracer of \[14C\] AG-120 (\~ 200 μCi) under fasted conditions. The study drug will be administered as an oral suspension with approximately 240 mL of room temperature, non-carbonated water. Blood, urine, and fecal samples (and vomitus, if applicable) will be collected throughout the study for pharmacokinetic (PK), mass balance, and/or clinical laboratory assessments. Safety will be monitored throughout the study. Subjects will be discharged from the clinical site from Day 22 to Day 29, depending on the recovery of eliminated radioactivity. Urine and fecal samples will be collected each day until Day 29 (or the point of discharge if earlier) for measurement of total \[14C\] radioactivity. Blood samples for radioanalysis and PK assessment, inclusive of metabolite profiling/characterization, will be collected at pre-dose and at specified intervals through Day 29. Total \[14C\]-radioactivity in whole blood, plasma, urine, and feces (and vomitus, if applicable ) will be determined. Up to 8 subjects will enroll in the study. One to two additional subjects who have been confirmed as having poor metabolizer (PM) CYP2D6 genotype may be enrolled.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-AG-120	Labeled investigational drug

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2015-07-03
• Last updated: 2015-12-14

Locations

1 site across 1 country: United States