NCT03703505

A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348

A Phase I, Open-label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion and to Assess the Absolute Bioavailability of AG-348 in Healthy Male Subjects Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348

• 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

This study will assess absorption, distribution, metabolism, excretion and absolute bioavailability of AG-348 in healthy male participants. Potential participants will be screened within 29 days prior to dose administration to determine eligibility. Eligible Participants will be admitted into the Clinical Research Unit (CRU) one day prior to administration of AG-348 and will be confined to the CRU until at least Day 8. If participants are not eligible for discharge on Day 8, they may remain in the CRU up to Day 11. Radiolabelled analytes of AG-348 will be administered in a single oral and intravenous (IV) dose on Day 1. Participants will be required to fast pre-dose, remain in a supine position for 1 hour post-dose and avoid water for 2 hours post-dose.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AG-348	120 milligrams (mg) oral capsule, single dose, contains 100 microcuries (μCi) of radio labelled \[14C\]AG-348.
DRUG	[13C6]AG-348	IV microdose of approximately 100 micrograms (mcg), single dose.

Timeline

• Start date: 2018-05-24
• Primary completion: 2018-06-01
• Completion: 2018-06-04
• First posted: 2018-10-12
• Last updated: 2018-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study