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Clinical Trials in the USA / NCT07868926
Recruiting Phase 1

Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose

NCT07868926 · tracked via the Priya Life Science USA tracker
Sponsor
Vertex Pharmaceuticals Incorporated
Phase
Phase 1
Started
2026-10-16
Last updated
2026-10-30

Condition(s) studied

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Investigational drug(s) / intervention(s)

14C-VX-407

14C-VX-407: Solution for Oral Administration.

Study summary

The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of VX-407 following a single oral dose.

Eligibility

Sex
MALE
Min age
19 Years
Max age
55 Years
Healthy volunteers
Accepted
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 day) Key Exclusion Criteria: * History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * Any condition possibly affecting drug absorption, distribution, metabolism, or excretion * Exposure to any nonenvironmental radiation (e.g., diagnostic medical imaging or occupational exposure) within 12 months before study drug administration * Participation in more than 1 radiolabeled study (if the previous study's radiation exposure is unknown) or participation in more than 3 radiolabeled studies (if the previous studies' radiation exposure is known) in the 12 months before dosing or if the annual whole-body radiation exposure from all previous studies (including this dosing) is more than the FDA-allowed maximum whole body radiation exposure of 5000 mrem Other protocol defined Inclusion/Exclusion criteria will apply.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Celerion - Lincoln Lincoln Nebraska Recruiting

More Vertex Pharmaceuticals Incorporated trials in the USA

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy Recruiting
A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) Active, not recruiting
An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant Recruiting
A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation Active, not recruiting
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants Recruiting

Other trials for the same condition

Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease Active, not recruiting
Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07868926 on ClinicalTrials.gov ↗ ← All trials in the USA