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
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
8actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-12-20 | actual | When the study began enrolling |
| Primary completion | 2025-02-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-02-21 | actual | The whole study's end, after follow-up |
| First posted | 2024-12-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-03-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants
Interventions
- Drug: [14C]-tebapivat
- Drug: [13C2,15N3]-tebapivat
Primary outcomes
what the primary-completion date above is the date OFPercentage of Radioactive Dose Excreted in Urine Over a Time Interval (feut1-t2) of [14C]-Tebapivat
measured Up to Day 42
Percentage of Radioactive Dose Excreted in Feces Over a Time Interval (fef t1-t2) of [14C]-Tebapivat
measured Up to Day 42
Cumulative Percentage of Radioactive Dose Excreted in Urine Over a Time Interval (Cum feut1-t2) of [14C]-Tebapivat
measured Up to Day 42
Cumulative Percentage of Radioactive Dose Excreted in Feces Over a Time Interval (Cum fef t1-t2) of [14C]-Tebapivat
measured Up to Day 42
Percentage of Total Radioactivity in Total Excreta (Feces + Urine) (Cum fe) of [14C]-Tebapivat
measured Up to Day 42
Amount of Drug Excreted in Urine (Aeu) of [14C]-Tebapivat
measured Up to Day 42
Cumulative Amount of Drug Excreted in Urine (Cum Aeu) of [14C]-Tebapivat
measured Up to Day 42
Renal Clearance (CLR) of [14C]-Tebapivat
measured Up to Day 42
Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hours Postdose (AUC0-168) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
measured Up to Day 7
AUC0-168 in Plasma and Whole Blood for Total Radioactivity
measured Up to Day 7
AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
measured Up to Day 21
AUC0-t in Plasma and Whole Blood for Total Radioactivity
measured Up to Day 42
AUC Extrapolated to Infinity (AUC0-inf) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
measured Up to Day 21
(AUC0-inf) in Plasma and Whole Blood for Total Radioactivity
measured Up to Day 42
Maximum Observed Plasma Concentration (Cmax) for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
measured Up to Day 21
Cmax in Plasma and Whole Blood for Total Radioactivity
measured Up to Day 42
Time to Reach Cmax (Tmax) for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
measured Up to Day 21
Tmax in Plasma and Whole Blood for Total Radioactivity
measured Up to Day 42
Terminal Elimination Half-Life (t1/2) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
measured Up to Day 21
T1/2 in Plasma and Whole Blood for Total Radioactivity
measured Up to Day 42
Ratio of AUC0-inf for Tebapivat to AUC0-inf for Total Radioactivity in Plasma
measured Up to Day 42
Ratio of AUC0-inf for Total Radioactivity in Whole Blood to AUC0-inf for Total Radioactivity in Plasma
measured Up to Day 42
Total Clearance Following IV Administration (CL) of [13C2,15N3]-Tebapivat
measured Up to Day 21
Apparent Volume of Distribution During the Terminal Phase Following IV Administration (Vz) of [13C2,15N3]-Tebapivat
measured Up to Day 21
Apparent Volume of Distribution at Steady State Following IV Administration (Vss) of [13C2,15N3]-Tebapivat
measured Up to Day 21
Ratio of Dose-Normalized AUC0-inf of Oral Administration of [14C]-Tebapivat Relative to IV Administration of [13C2,15N3]-Tebapivat
measured Up to Day 21
Quantitation of Major Metabolites of [14C]-Tebapivat in Plasma After Oral Administration
measured Up to Day 21
Quantitation of Major Metabolites of [14C]-Tebapivat in Excreta After Oral Administration
measured Up to Day 42
Identification of Chemical Structure of Major Metabolites of [14C]-Tebapivat in Plasma After Oral Administration
measured Up to Day 21
Identification of Chemical Structure of Major Metabolites of [14C]-Tebapivat in Excreta After Oral Administration
measured Up to Day 42
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