Recruiting
Phase 1

VX-407

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07868926

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Eligibility Criteria

Sex: Male

Age: 19 - 55

Healthy Volunteers: Accepted

Interventions

14C-VX-407

Study Details

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)

Study ID

NCT07868926

Start date

Oct 16, 2026

Status verified date

Oct, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 19 - 55

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.

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 14C-VX-407

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

Interventions

14C-VX-407

Solution for Oral Administration.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

Celerion - Lincoln

Recruiting

Lincoln, Nebraska, United States, 68502

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.