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14C-VX-993

Phase 1

Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Last Updated: Jun 18, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

14C-VX-993 · 1 trial · 1 indication

Phase 1 1
NCT06886269A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral DosePain
COMPLETED8 Analytics
PHASE1COMPLETED
A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral Dose
PainUnlock trial analytics

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 to 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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Frequently asked questions about 14C-VX-993

What is 14C-VX-993 used for?

14C-VX-993 is an investigational small molecule being developed for the treatment of pain. It is currently in Phase 1 clinical development, with a completed study evaluating how the body processes the drug after a single oral dose. The drug is not yet approved and remains under investigation.

Who makes 14C-VX-993?

14C-VX-993 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical research to evaluate the drug's pharmacokinetics in healthy volunteers.

What phase is 14C-VX-993 in?

14C-VX-993 is in Phase 1 clinical development. A single Phase 1 study has been completed, which evaluated how the body processes the drug after a single oral dose. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is 14C-VX-993 in?

14C-VX-993 has one completed clinical trial, identified as NCT06886269. This Phase 1 study evaluated how the body processes 14C-VX-993 after a single oral dose in healthy male volunteers aged 18 years and older in the United States. The trial enrolled 8 participants.

Is 14C-VX-993 FDA approved?

14C-VX-993 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for pain. A single Phase 1 study has been completed, but the drug remains under investigation and has not been authorized for marketing.