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-TVB-2640

Phase 1

Healthy Volunteers | Small molecule | Other |Sagimet Biosciences Inc. - Series A|Last Updated: Dec 28, 2022

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
NCT05657834Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male SubjectsPHASE1 COMPLETED 8Nov 21, 2022Dec 21, 2022Dec 28, 20221 United States
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Study Endpoints
Primary Endpoints
[14C]TVB-2640: AUC-inf in plasma
Up to 22 days
[14C]TVB-2640: Amount excreted in urine
Up to 22 days
[14C]TVB-2640: Amount excreted in feces
Up to 22 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment Arm 1EXPERIMENTALSingle dose of TVB-2640, 50 mg, oral administration
Interventions
NameTypeDescription
[14C]-TVB-2640DRUG50 mg of TVB-2640 oral administration
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Eligibility Criteria
Age Range19 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Males, of any race, between 19 and 55 years of age, inclusive. * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic ...

Countries:United States
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