NCT06745271

A Study to Determine How Tebapivat is Absorbed, Broken Down, and Removed From the Body and the Extent to Which Tebapivat is Made Available in the Body in Healthy Participants

A Phase I, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion and to Assess the Absolute Bioavailability Following a Single Oral Dose of [14C]-Tebapivat and Concomitant Single Intravenous Microdose of [13C2,15N3]-Tebapivat to Healthy Male Participants

• 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 primary purpose of this study is to determine the routes, rates of elimination, mass balance of total radioactivity and metabolite profiles following a single oral dose of \[14C\]-tebapivat. To characterize the PK of tebapivat and \[13C2,15N3\]-tebapivat and determine the absolute bioavailability following single oral dose of \[14C\]-tebapivat relative to single intravenous microdose of \[13C2,15N3\]-tebapivat to healthy male participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	[14C]-tebapivat	Oral Capsule
DRUG	[13C2,15N3]-tebapivat	Intravenous Solution

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-02-21
• Completion: 2025-02-21
• First posted: 2024-12-20
• Last updated: 2025-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study