drugset / Trial / 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

NCT06745271 ↗

Phase 1 Completed 8 enrolled Agios Pharmaceuticals, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-20
Primary completion
2025-02-21
Completion
2025-02-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Tebapivat Small molecule 0.1 mg Oral
Subject Tebapivat Small molecule 10 mg Oral

Indications

No indication recorded.