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Not yet recruitingNCT07868926Updated Oct 9, 2026

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

A Phase 1 interventional study of 14C-VX-407 in Autosomal Dominant Polycystic Kidney Disease (ADPKD), sponsored by Vertex Pharmaceuticals Incorporated. Not yet recruiting. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1, Interventional, and Treatment

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
19 Years to 55 Years
Sex
Male
01

Study summary

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

Read the detailed description

The purpose of the study is to evaluate the pharmacokinetics of VX-407 following a single oral dose. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

02

Conditions studied

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD)
03

In context

Polycystic Kidney, Autosomal Dominant

177 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 39 are open to participants now.

This study's planned enrollment of 8 is below the median of 51 across 132 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.

Browse Polycystic Kidney, Autosomal Dominant studies →

Lead sponsor

Vertex Pharmaceuticals Incorporated is the lead sponsor of 249 studies on the registry; 20 are open to participants now.

Of its 106 completed or terminated interventional studies of FDA-regulated products, 53 (50%) have results posted.

Browse Vertex Pharmaceuticals Incorporated studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study 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.

    Drug: 14C-VX-407

Interventions

  • Drug14C-VX-407

    Solution for Oral Administration.

06

What researchers measure

Primary outcomes

  1. 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

  2. Terminal Phase Rate Constant (λz) of VX-407 in Plasma

    Time frame: From Day 1 up to Day 30

  3. 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

  4. 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

  5. Apparent Clearance (CL/F) of VX-407 in Plasma

    Time frame: From Day 1 up to Day 30

  6. Renal Clearance (CLr) of VX-407

    Time frame: From Day -1 up to Day 30

  7. Maximum Observed Plasma Concentration (Cmax) of VX-407 in Plasma

    Time frame: From Day 1 up to Day 30

  8. 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

  9. Fraction (percent) of Dose Excreted Unchanged in Urine of VX-407 (fe)

    Time frame: From Day -1 up to Day 30

  10. 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

  11. Terminal Phase Rate Constant (λz) of Total Radioactivity (TRA) in Whole blood and Plasma

    Time frame: From Day 1 up to Day 30

  12. AUC0-tlast of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 30

  13. AUC0-inf of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 30

  14. CL/F of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 30

  15. Cmax of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 30

  16. Fraction (percent) of Dose Excreted Unchanged in Urine of TRA

    Time frame: From Day -1 up to Day 30

  17. 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

Secondary outcomes

  1. Metabolite Profiling and Identification in Plasma, Urine, and Feces

    Time frame: From Day 1 up to Day 30

  2. Terminal Phase Rate Constant (λz) of VX-407 Metabolites in Plasma

    Time frame: From Day 1 up to Day 30

  3. AUC0-tlast of VX-407 Metabolites in Plasma

    Time frame: From Day 1 up to Day 30

  4. AUC0-inf of VX-407 Metabolites in Plasma

    Time frame: From Day 1 up to Day 30

  5. Cmax of VX-407 Metabolites in Plasma

    Time frame: From Day 1 up to Day 30

  6. Tmax of VX-407 Metabolites in Plasma

    Time frame: From Day 1 up to Day 30

  7. Apparent Volume of Distribution (Based on the Terminal Phase) of VX-407 Metabolites in Plasma

    Time frame: From Day 1 up to Day 30

  8. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Day 41

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2026, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2026
First posted
Oct 9, 2026
StartEst.
Oct 19, 2026
Primary completionEst.
Dec 15, 2026
CompletionEst.
Dec 15, 2026
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07868926
Lead sponsor
Vertex Pharmaceuticals Incorporated
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Oct 19, 2026 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Oct 9, 2026

Study contacts

Medical Information
Contact
medicalinfo@vrtx.com
617-341-6777

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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