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

NCT06886269 | Completed Phase 1 FDA Drug

• 1 other identifier: VX24-993-007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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-VX-993.

Conditions

Pain

Outcome Measures

Primary Outcomes (18)

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

  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

  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

  From Day 1 up to Day 25

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

  From Day 1 up to Day 25

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

  From Day 1 up to Day 25

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

  From Day 1 up to Day 25

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

  From Day 1 up to Day 25

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

  From Day 1 up to Day 25

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

  Pre dose up to Day 25

• AUC0-tlast of TRA in Whole blood and Plasma

  From Day 1 up to Day 25

• AUC0-inf of TRA in Whole blood and Plasma

  From Day 1 up to Day 25

• CL/F of TRA in Whole blood and Plasma

  From Day 1 up to Day 25

• Renal Clearance (CLr) of TRA in Urine and Feces

  Pre dose up to Day 25

• Cmax of TRA in Whole blood and Plasma

  From Day 1 up to Day 25

• Fraction (percent) of Dose Excreted Unchanged in Urine of TRA

  Pre dose up to Day 25

• Tmax of TRA in Whole blood and Plasma

  From Day 1 up to Day 25

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

  From Day 1 up to Day 25

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

  From Day 1 up to Day 25

Secondary Outcomes (13)

• Metabolite Profiling and Identification in Plasma, Urine, and Feces

  From Day 1 up to Day 25

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

  From Day 1 up to Day 25

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

  Pre dose up to Day 25

• AUC0-last of VX-993 Metabolites in Plasma

  From Day 1 up to Day 25

• AUC0-inf of VX-993 Metabolites in Plasma

  From Day 1 up to Day 25

Study Arms (1)

14C VX-993

EXPERIMENTAL

Participants will receive a single oral dose of 14C-VX-993 after an overnight fast of at least 8 hours.

Drug: 14C-VX-993

Interventions

14C-VX-993 DRUG

Solution for Oral Administration.

14C VX-993

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Celerion - Lincoln

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: March 21, 2025
• Primary Completion: May 17, 2025
• Study Completion: May 17, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)