VX-407 pharmacokinetics after a single dose in adults with ADPKD
Official title: A Phase 1, Open-Label, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 Following Single Oral Administration in Healthy Subjects
Run by Vertex Pharmaceuticals Incorporated · NCT07868926 · Data updated 2026-11-12
This study tests how VX-407 is absorbed, distributed, metabolized, and excreted after a one-time oral dose in adults with polycystic kidney disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 55 Years |
| Sex | Men only |
| Enrollment | 8 (estimated) |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Lincoln, Nebraska) |
| Status | Recruiting |
| Started | October 16, 2026 |
| Main results expected | December 15, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07868926 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with autosomal dominant polycystic kidney disease who meet BMI, weight, and bowel movement criteria and have no conditions affecting drug handling.
✕Probably not a fit
Patients with comorbidities or conditions affecting absorption or radiation exposure limits may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional trial administers a single oral dose of radiolabeled VX-407 to eligible adults to characterize its pharmacokinetic profile. Safety and tolerability are also monitored to identify any immediate adverse effects. The study relies on precise measurement of the radiolabeled compound to track absorption, distribution, metabolism, and excretion. It is conducted at a single center with a sponsor focus on early pharmacology data for VX-407. Participants are selected by BMI, weight, stool frequency, and general health criteria to minimize variability.
Why it matters
Potential benefit: Participants may not directly benefit, but the information could help determine dosing for future studies of VX-407 in kidney disease.
How similar studies have gone: Prior pharmacokinetic studies using radiolabeled compounds have successfully mapped ADME profiles in early-phase trials, supporting this approach's validity.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Celerion - Lincoln
Lincoln, Nebraska, United States Recruiting
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.