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14C-VX-407

Phase 1

Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Small molecule | Nephrology |Vertex Pharmaceuticals Incorporated|Trials Updated: Oct 9, 2026

14C-VX-407 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

14C-VX-407 clinical trials

14C-VX-407 · 1 trial · 1 indication

Phase 1 1
NCT07868926Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral DoseAutosomal Dominant Polycystic Kidney Disease (ADPKD)
NOT YET_RECRUITING8 Analytics
PHASE1NOT YET_RECRUITING
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT078689268
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Study Endpoints

Primary Endpoints

Amount of Radioactivity Excreted (Ae) of 14C-VX-407 Total Radioactivity (TRA) in Urine, and Feces
From Day -1 up to Day 30
Terminal Phase Rate Constant (λz) of VX-407 in Plasma
From Day 1 up to Day 30
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-407 in Plasma
From Day 1 up to Day 30
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 in Plasma
From Day 1 up to Day 30
Apparent Clearance (CL/F) of VX-407 in Plasma
From Day 1 up to Day 30
Renal Clearance (CLr) of VX-407
From Day -1 up to Day 30
Maximum Observed Plasma Concentration (Cmax) of VX-407 in Plasma
From Day 1 up to Day 30
Time for VX-407 to Reach Maximum Concentration (Tmax) of VX-407 in Plasma and Urine
From Day 1 up to Day 30
Fraction (percent) of Dose Excreted Unchanged in Urine of VX-407 (fe)
From Day -1 up to Day 30
Apparent Volume of Distribution (Vz/F) (Based on the Terminal Phase) of VX-407 in Plasma
From Day 1 up to Day 30
Terminal Phase Rate Constant (λz) of Total Radioactivity (TRA) in Whole blood and Plasma
From Day 1 up to Day 30
AUC0-tlast of TRA in Whole blood and Plasma
From Day 1 up to Day 30
AUC0-inf of TRA in Whole blood and Plasma
From Day 1 up to Day 30
CL/F of TRA in Whole blood and Plasma
From Day 1 up to Day 30
Cmax of TRA in Whole blood and Plasma
From Day 1 up to Day 30
Fraction (percent) of Dose Excreted Unchanged in Urine of TRA
From Day -1 up to Day 30
Apparent Volume of Distribution (Based on the Terminal Phase) of TRA in Whole blood and Plasma
From Day 1 up to Day 30

Secondary Endpoints

Metabolite Profiling and Identification in Plasma, Urine, and Feces
From Day 1 up to Day 30
Terminal Phase Rate Constant (λz) of VX-407 Metabolites in Plasma
From Day 1 up to Day 30
AUC0-tlast of VX-407 Metabolites in Plasma
From Day 1 up to Day 30
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
14C-VX-407EXPERIMENTALParticipants will receive a single oral dose of 14C-VX-407 after an overnight fast of at least 8 hours.

Interventions

NameTypeDescription
14C-VX-407DRUGSolution for Oral Administration.
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Eligibility Criteria

Age Range19 Years to 55 Years
SexMALE
Healthy VolunteersYes

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 regular bowel movements (i.e., average of more than or equal to (\>=) 1 and less than or equal to (\<=)3 stools per d...

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Recent Changes (Last 90 Days)

LOWOct 9, 2026NCT07868926NEW_TRIAL: changed
LOWOct 9, 2026NCT07868926NEW_TRIAL: changed

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