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14C-VX-993

Phase 1

Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Last Updated: Jun 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
NCT06886269A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral DosePHASE1 COMPLETED 8 — — Mar 21, 2025May 17, 2025Jun 18, 20251 United States
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Study Endpoints
Primary Endpoints
Terminal Phase Rate Constant (λz) of VX-993 in Plasma
From Day 1 up to Day 25
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-993 in Plasma
From Day 1 up to Day 25
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 in Plasma
From Day 1 up to Day 25
Apparent Clearance (CL/F) of VX-993 in Plasma
From Day 1 up to Day 25
Maximum Observed Plasma Concentration (Cmax) of VX-993 in Plasma
From Day 1 up to Day 25
Time for VX-993 to Reach Maximum Concentration (Tmax) in Plasma
From Day 1 up to Day 25
Apparent Volume of Distribution (Vz/F) (Based on the Terminal Phase) of VX-993 in Plasma
From Day 1 up to Day 25
Terminal Phase Rate Constant (λz) of Total Radioactivity (TRA) in Whole blood and Plasma
From Day 1 up to Day 25
Amount of Radioactivity Excreted (Ae) of TRA in Urine, Feces and Vomitus (if applicable)
Pre dose up to Day 25
AUC0-tlast of TRA in Whole blood and Plasma
From Day 1 up to Day 25
AUC0-inf of TRA in Whole blood and Plasma
From Day 1 up to Day 25
CL/F of TRA in Whole blood and Plasma
From Day 1 up to Day 25
Renal Clearance (CLr) of TRA in Urine and Feces
Pre dose up to Day 25
Cmax of TRA in Whole blood and Plasma
From Day 1 up to Day 25
Fraction (percent) of Dose Excreted Unchanged in Urine of TRA
Pre dose up to Day 25
Tmax of TRA in Whole blood and Plasma
From Day 1 up to Day 25
Apparent Volume of Distribution (Based on the Terminal Phase) of TRA in Whole blood and Plasma
From Day 1 up to Day 25
Amount of VX-993 and Metabolites, Expressed as a percent of TRA, in Plasma, Urine and Feces
From Day 1 up to Day 25
Secondary Endpoints
Metabolite Profiling and Identification in Plasma, Urine, and Feces
From Day 1 up to Day 25
Terminal Phase Rate Constant (λz) of VX-993 Metabolites in Plasma and Urine (if applicable)
From Day 1 up to Day 25
Amount of radioactivity excreted (Ae) of VX-993 Metabolites in Urine and Feces
Pre dose up to Day 25
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
14C VX-993EXPERIMENTALParticipants will receive a single oral dose of 14C-VX-993 after an overnight fast of at least 8 hours.
Interventions
NameTypeDescription
14C-VX-993DRUGSolution for Oral Administration.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive * A total body weight of more than (\>) 50 kg * Participants must have at least 1 regular bowel movement per day Key Exclusion Criteria: * History of febrile illness or other acute illne...

Countries:United States
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