NCT06886269

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	14C-VX-993	Solution for Oral Administration.

Timeline

• Start date: 2025-03-21
• Primary completion: 2025-05-17
• Completion: 2025-05-17
• First posted: 2025-03-20
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study