Status:
COMPLETED
A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral Dose
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Pain
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06886269
Start Date
March 21 2025
End Date
May 17 2025
Last Update
June 18 2025
Active Locations (1)
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1
Celerion - Lincoln
Lincoln, Nebraska, United States, 68502