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14C RPT193

Phase 1

Healthy Male Subjects | Small molecule | Other |RAPT Therapeutics, Inc.|Last Updated: Nov 29, 2023

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 Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06087978Study of RPT193 in Healthy Adult Male SubjectsPHASE1 COMPLETED 7Jul 5, 2023Oct 12, 2023Nov 29, 20231 United States
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Study Endpoints
Primary Endpoints
Route(s) of elimination 1
14 days

Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces

Route(s) of elimination 2
14 days

Percent (%) of radioactive drug excreted as TRA in urine and feces

Quantitate total radioactivity (TRA)
14 days

Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces

Characterize pharmacokinetics (PK) profile of RPT193
14 days

Calculation of area under the curve (AUC) in plasma and urine

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
14C RPT193 400 mgEXPERIMENTALRadiolabelled RPT193
Interventions
NameTypeDescription
14C RPT193DRUGRadiolabelled RPT193
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Eligibility Criteria
Age Range19 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening Exclusion Criteria: * Is mentally or legally incapacitated or has significant emotional pro...

Countries:United States
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