CompletedPhase 1

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

United States8 participantsStarted 2025-03-21

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 at least 1 regular bowel movement 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 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Trial details

NCT IDNCT06886269

SponsorVertex Pharmaceuticals Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-17

View on ClinicalTrials.gov More Pain trials

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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

Timeframe: From Day 1 up to Day 25

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