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-tebapivat

Phase 1

Healthy Participants | Small molecule | Other |Agios Pharmaceuticals, Inc.|Last Updated: Mar 18, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06745271A 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 ParticipantsPHASE1 COMPLETED 8 — — Dec 20, 2024Feb 21, 2025Mar 18, 20251 United States
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Study Endpoints
Primary Endpoints
Percentage of Radioactive Dose Excreted in Urine Over a Time Interval (feut1-t2) of [14C]-Tebapivat
Up to Day 42
Percentage of Radioactive Dose Excreted in Feces Over a Time Interval (fef t1-t2) of [14C]-Tebapivat
Up to Day 42
Cumulative Percentage of Radioactive Dose Excreted in Urine Over a Time Interval (Cum feut1-t2) of [14C]-Tebapivat
Up to Day 42
Cumulative Percentage of Radioactive Dose Excreted in Feces Over a Time Interval (Cum fef t1-t2) of [14C]-Tebapivat
Up to Day 42
Percentage of Total Radioactivity in Total Excreta (Feces + Urine) (Cum fe) of [14C]-Tebapivat
Up to Day 42
Amount of Drug Excreted in Urine (Aeu) of [14C]-Tebapivat
Up to Day 42
Cumulative Amount of Drug Excreted in Urine (Cum Aeu) of [14C]-Tebapivat
Up to Day 42
Renal Clearance (CLR) of [14C]-Tebapivat
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
Up to Day 7
AUC0-168 in Plasma and Whole Blood for Total Radioactivity
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
Up to Day 21
AUC0-t in Plasma and Whole Blood for Total Radioactivity
Up to Day 42
AUC Extrapolated to Infinity (AUC0-inf) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Up to Day 21
(AUC0-inf) in Plasma and Whole Blood for Total Radioactivity
Up to Day 42
Maximum Observed Plasma Concentration (Cmax) for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Up to Day 21
Cmax in Plasma and Whole Blood for Total Radioactivity
Up to Day 42
Time to Reach Cmax (Tmax) for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Up to Day 21
Tmax in Plasma and Whole Blood for Total Radioactivity
Up to Day 42
Terminal Elimination Half-Life (t1/2) in Plasma for [14C]-Tebapivat and [13C2,15N3]-Tebapivat
Up to Day 21
T1/2 in Plasma and Whole Blood for Total Radioactivity
Up to Day 42
Ratio of AUC0-inf for Tebapivat to AUC0-inf for Total Radioactivity in Plasma
Up to Day 42
Ratio of AUC0-inf for Total Radioactivity in Whole Blood to AUC0-inf for Total Radioactivity in Plasma
Up to Day 42
Total Clearance Following IV Administration (CL) of [13C2,15N3]-Tebapivat
Up to Day 21
Apparent Volume of Distribution During the Terminal Phase Following IV Administration (Vz) of [13C2,15N3]-Tebapivat
Up to Day 21
Apparent Volume of Distribution at Steady State Following IV Administration (Vss) of [13C2,15N3]-Tebapivat
Up to Day 21
Ratio of Dose-Normalized AUC0-inf of Oral Administration of [14C]-Tebapivat Relative to IV Administration of [13C2,15N3]-Tebapivat
Up to Day 21
Quantitation of Major Metabolites of [14C]-Tebapivat in Plasma After Oral Administration
Up to Day 21

Quantification of major metabolites of \[14C\]-tebapivat in plasma.

Quantitation of Major Metabolites of [14C]-Tebapivat in Excreta After Oral Administration
Up to Day 42

Quantification of major metabolites of \[14C\]-tebapivat in excreta.

Identification of Chemical Structure of Major Metabolites of [14C]-Tebapivat in Plasma After Oral Administration
Up to Day 21

Identification of the chemical structures of major metabolites of \[14C\]-tebapivat in plasma.

Identification of Chemical Structure of Major Metabolites of [14C]-Tebapivat in Excreta After Oral Administration
Up to Day 42

Identification of the chemical structures of major metabolites of \[14C\]-tebapivat in excreta.

Secondary Endpoints
Number of Participants with Adverse Events (AEs) by Type, Severity, and Relationship to Study Drug
Up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Assessments
Baseline up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Abnormal 12-Lead Electrocardiogram (ECG) Parameters
Baseline up to Day 28
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[14C]-tebapivat and [13C2,15N3]-tebapivatEXPERIMENTALParticipants will receive a single oral dose of 10 milligrams (mg) \[14C\]-tebapivat containing 200 microcurie \[μCi\] of radiocarbon in a capsule followed by a single intravenous (IV) microdose of 0.1 mg \[13C2,15N3\]-tebapivat on Day 1.
Interventions
NameTypeDescription
[14C]-tebapivatDRUGOral Capsule
[13C2,15N3]-tebapivatDRUGIntravenous Solution
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male, of any race, between 18 and 55 years of age, inclusive. a. Males must agree to use contraception. 2. Body mass index between 18.0 and 30.0 kilograms per meter square (kg/m2), inclusive, and a body weight between 50 and 100 kilograms (kg), inclusive. 3. In good healt...

Countries:United States
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