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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-21

Study Completion Date

2025-05-17

Brief Summary

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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.

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Detailed Description

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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

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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14C VX-993

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

Group Type EXPERIMENTAL

14C-VX-993

Intervention Type DRUG

Solution for Oral Administration.

Interventions

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14C-VX-993

Solution for Oral Administration.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes