clinical 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
Healthy Participants[14C]-tebapivat[13C2,15N3]-tebapivat
brief 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.
started
Dec 20, 2024
primary completion
Feb 21, 2025
completion
Feb 21, 2025
last updated
Mar 18, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol