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

A Phase I, Open-label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion, and to Assess the Absolute Bioavailability of AG-881 in Healthy Male Subjects Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Participants

Interventions

Type	Name	Description
DRUG	AG-881	Single oral dose of approximately 50 mg AG-881 (free form) containing approximately 100 microcuries (μCi) of \[14C\]AG-881.
DRUG	[13C315N3]AG-881	Single IV microdose of approximately 100 μg.

Timeline

• Start date: 2019-05-16
• Primary completion: 2019-09-07
• Completion: 2019-09-07
• First posted: 2019-05-23
• Last updated: 2019-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study