Autosomal Dominant Polycystic Kidney Disease (ADPKD)Phase 1NCT07868926
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
A Phase 1 study testing 14C-VX-407 in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Vertex Pharmaceuticals Incorporated at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of VX-407 following a single oral dose. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- What is being tested?
- 14C-VX-407
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2026to 15 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Celerion - Lincoln
Lincoln, Nebraska, 68502
About this study
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
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.).
- Being tested
- 14C-VX-407
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-VX-407Drug
Solution for Oral Administration.
| Study group | Role | What they receive |
|---|---|---|
| 14C-VX-407 | Experimental | Participants will receive a single oral dose of 14C-VX-407 after an overnight fast of at least 8 hours. Receives: Drug: 14C-VX-407 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Radioactivity Excreted (Ae) of 14C-VX-407 Total Radioactivity (TRA) in Urine, and Feces
Measured: From Day -1 up to Day 30
Terminal Phase Rate Constant (λz) of VX-407 in Plasma
Measured: 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
Measured: 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
Measured: From Day 1 up to Day 30
Apparent Clearance (CL/F) of VX-407 in Plasma
Measured: From Day 1 up to Day 30
Renal Clearance (CLr) of VX-407
Measured: From Day -1 up to Day 30
Maximum Observed Plasma Concentration (Cmax) of VX-407 in Plasma
Measured: From Day 1 up to Day 30
Time for VX-407 to Reach Maximum Concentration (Tmax) of VX-407 in Plasma and Urine
Measured: From Day 1 up to Day 30
Fraction (percent) of Dose Excreted Unchanged in Urine of VX-407 (fe)
Measured: From Day -1 up to Day 30
Apparent Volume of Distribution (Vz/F) (Based on the Terminal Phase) of VX-407 in Plasma
Measured: From Day 1 up to Day 30
Terminal Phase Rate Constant (λz) of Total Radioactivity (TRA) in Whole blood and Plasma
Measured: From Day 1 up to Day 30
AUC0-tlast of TRA in Whole blood and Plasma
Measured: From Day 1 up to Day 30
AUC0-inf of TRA in Whole blood and Plasma
Measured: From Day 1 up to Day 30
CL/F of TRA in Whole blood and Plasma
Measured: From Day 1 up to Day 30
Cmax of TRA in Whole blood and Plasma
Measured: From Day 1 up to Day 30
Fraction (percent) of Dose Excreted Unchanged in Urine of TRA
Measured: From Day -1 up to Day 30
Apparent Volume of Distribution (Based on the Terminal Phase) of TRA in Whole blood and Plasma
Measured: From Day 1 up to Day 30
Secondary outcomes (8)
Metabolite Profiling and Identification in Plasma, Urine, and Feces
Measured: From Day 1 up to Day 30
Terminal Phase Rate Constant (λz) of VX-407 Metabolites in Plasma
Measured: From Day 1 up to Day 30
AUC0-tlast of VX-407 Metabolites in Plasma
Measured: From Day 1 up to Day 30
AUC0-inf of VX-407 Metabolites in Plasma
Measured: From Day 1 up to Day 30
Cmax of VX-407 Metabolites in Plasma
Measured: From Day 1 up to Day 30
Tmax of VX-407 Metabolites in Plasma
Measured: From Day 1 up to Day 30
Apparent Volume of Distribution (Based on the Terminal Phase) of VX-407 Metabolites in Plasma
Measured: From Day 1 up to Day 30
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to Day 41
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start16 Oct 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868926
- Sponsor's protocol ID
- VX24-407-009
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07868926
- Acronym / sponsor ID
- VX24-407-009
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of VX-407 following a single oral dose.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-VX-407 | Experimental | Drug: 14C-VX-407Participants will receive a single oral dose of 14C-VX-407 after an overnight fast of at least 8 hours. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14C-VX-407Solution for Oral Administration. | Drug | 14C-VX-407 |
Primary outcome
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
8 secondary outcomes
Metabolite Profiling and Identification in Plasma, Urine, and Feces
Time frame: From Day 1 up to Day 30
Terminal Phase Rate Constant (λz) of VX-407 Metabolites in Plasma
Time frame: From Day 1 up to Day 30
AUC0-tlast of VX-407 Metabolites in Plasma
Time frame: From Day 1 up to Day 30
AUC0-inf of VX-407 Metabolites in Plasma
Time frame: From Day 1 up to Day 30
Cmax of VX-407 Metabolites in Plasma
Time frame: From Day 1 up to Day 30
Tmax of VX-407 Metabolites in Plasma
Time frame: From Day 1 up to Day 30
Apparent Volume of Distribution (Based on the Terminal Phase) of VX-407 Metabolites in Plasma
Time frame: From Day 1 up to Day 30
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 14C-VX-407 in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Vertex Pharmaceuticals Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (617-341-6777, medicalinfo@vrtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.