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

NCT07868926 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: VX24-407-009
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (8)

• 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

• AUC0-inf of VX-407 Metabolites in Plasma

  From Day 1 up to Day 30

• Cmax of VX-407 Metabolites in Plasma

  From Day 1 up to Day 30

Study Arms (1)

14C-VX-407

EXPERIMENTAL

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

Drug: 14C-VX-407

Interventions

14C-VX-407 DRUG

Solution for Oral Administration.

14C-VX-407

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Central Study Contacts

Medical Information

CONTACT

617-341-6777; medicalinfo@vrtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share