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PainPhase 1NCT06886269

A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral Dose

A Phase 1 study testing 14C-VX-993 in people with Pain, run by Vertex Pharmaceuticals Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate the routes and rate of elimination and recovery of total radioactivity (TRA) and characterize the Pharmacokinetic (PK) of VX-993 after a single oral dose of 14C-VX-993. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
14C-VX-993
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
21 Mar 2025to 17 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 18 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 at least 1 regular bowel movement 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 non-environmental radiation within 12 months of dosing
  • Participation in more than 1 radiolabeled study (if prior radiation exposure unknown) or participation in more than 3 radiolabeled studies (if radiation exposure known) in the 12 months before dosing or if the annual whole body radiation exposure from previous studies (including this dosing) exceeds FDA-allowed maximum whole body radiation exposure of 5000 mrem
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion - Lincoln

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-VX-993 Following Single Oral Administration in Healthy Subjects

The purpose of the study is to evaluate the routes and rate of elimination and recovery of total radioactivity (TRA) and characterize the Pharmacokinetic (PK) of VX-993 after a single oral dose of 14C-VX-993.

Read the detailed description

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.)

Conditions
Pain
Being tested
14C-VX-993
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 14C-VX-993Drug

    Solution for Oral Administration.

Study groups in NCT06886269
Study groupRoleWhat they receive
14C VX-993ExperimentalParticipants will receive a single oral dose of 14C-VX-993 after an overnight fast of at least 8 hours.
Receives: Drug: 14C-VX-993

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Terminal Phase Rate Constant (λz) of VX-993 in Plasma

    Measured: From Day 1 up to Day 25

  2. Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-993 in Plasma

    Measured: From Day 1 up to Day 25

  3. Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 in Plasma

    Measured: From Day 1 up to Day 25

  4. Apparent Clearance (CL/F) of VX-993 in Plasma

    Measured: From Day 1 up to Day 25

  5. Maximum Observed Plasma Concentration (Cmax) of VX-993 in Plasma

    Measured: From Day 1 up to Day 25

  6. Time for VX-993 to Reach Maximum Concentration (Tmax) in Plasma

    Measured: From Day 1 up to Day 25

  7. Apparent Volume of Distribution (Vz/F) (Based on the Terminal Phase) of VX-993 in Plasma

    Measured: From Day 1 up to Day 25

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

    Measured: From Day 1 up to Day 25

  9. Amount of Radioactivity Excreted (Ae) of TRA in Urine, Feces and Vomitus (if applicable)

    Measured: Pre dose up to Day 25

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

    Measured: From Day 1 up to Day 25

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

    Measured: From Day 1 up to Day 25

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

    Measured: From Day 1 up to Day 25

  13. Renal Clearance (CLr) of TRA in Urine and Feces

    Measured: Pre dose up to Day 25

  14. Cmax of TRA in Whole blood and Plasma

    Measured: From Day 1 up to Day 25

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

    Measured: Pre dose up to Day 25

  16. Tmax of TRA in Whole blood and Plasma

    Measured: From Day 1 up to Day 25

  17. Apparent Volume of Distribution (Based on the Terminal Phase) of TRA in Whole blood and Plasma

    Measured: From Day 1 up to Day 25

  18. Amount of VX-993 and Metabolites, Expressed as a percent of TRA, in Plasma, Urine and Feces

    Measured: From Day 1 up to Day 25

Secondary outcomes (13)

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

    Measured: From Day 1 up to Day 25

  2. Terminal Phase Rate Constant (λz) of VX-993 Metabolites in Plasma and Urine (if applicable)

    Measured: From Day 1 up to Day 25

  3. Amount of radioactivity excreted (Ae) of VX-993 Metabolites in Urine and Feces

    Measured: Pre dose up to Day 25

  4. AUC0-last of VX-993 Metabolites in Plasma

    Measured: From Day 1 up to Day 25

  5. AUC0-inf of VX-993 Metabolites in Plasma

    Measured: From Day 1 up to Day 25

  6. CL/F of VX-993 Metabolites in Plasma

    Measured: From Day 1 up to Day 25

  7. CLr of VX-993 Metabolites in Urine

    Measured: From Day 1 up to Day 25

  8. Cmax of VX-993 Metabolites in Plasma

    Measured: From Day 1 up to Day 25

  9. Fraction (percent) of Dose Excreted Unchanged in Urine of VX-993 Metabolites

    Measured: Pre dose up to Day 25

  10. Tmax of VX-993 Metabolites in Plasma

    Measured: Day 1 up to Day 25

  11. Apparent Volume of Distribution (Based on the Terminal Phase) of VX-993 Metabolites in Plasma

    Measured: Day 1 up to Day 25

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

    Measured: Day 1 up to Day 35

  13. Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses

    Measured: Pre-dose up to Day 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start21 Mar 2025
  3. Primary completion17 May 2025
  4. Study completion17 May 2025

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06886269
Sponsor's protocol ID
VX24-993-007
Status last verified
Jun 2025
First submitted
14 Mar 2025
Last updated
18 Jun 2025
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/independent-research/clinical-trial-data-sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 14C-VX-993 in people with Pain, 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: finished, as of the sponsor's last update on 18 Jun 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Terminal Phase Rate Constant (λz) of VX-993 in Plasma (time frame: From Day 1 up to Day 25). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06886269.

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 18 Jun 2025; AzTrials last refreshed its copy on 2 Nov 2026.

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