Clinical trial NCT06886269: A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral Dose
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.)

Eligibility criteria: 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.

Primary outcomes:
measure: Terminal Phase Rate Constant (λz) of VX-993 in Plasma
timeFrame: From Day 1 up to Day 25
measure: 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
measure: 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
measure: Apparent Clearance (CL/F) of VX-993 in Plasma
timeFrame: From Day 1 up to Day 25
measure: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Plasma
timeFrame: From Day 1 up to Day 25
measure: Time for VX-993 to Reach Maximum Concentration (Tmax) in Plasma
timeFrame: From Day 1 up to Day 25
measure: Apparent Volume of Distribution (Vz/F) (Based on the Terminal Phase) of VX-993 in Plasma
timeFrame: From Day 1 up to Day 25
measure: Terminal Phase Rate Constant (λz) of Total Radioactivity (TRA) in Whole blood and Plasma
timeFrame: From Day 1 up to Day 25
measure: Amount of Radioactivity Excreted (Ae) of TRA in Urine, Feces and Vomitus (if applicable)
timeFrame: Pre dose up to Day 25
measure: AUC0-tlast of TRA in Whole blood and Plasma
timeFrame: From Day 1 up to Day 25
measure: AUC0-inf of TRA in Whole blood and Plasma
timeFrame: From Day 1 up to Day 25
measure: CL/F of TRA in Whole blood and Plasma
timeFrame: From Day 1 up to Day 25
measure: Renal Clearance (CLr) of TRA in Urine and Feces
timeFrame: Pre dose up to Day 25
measure: Cmax of TRA in Whole blood and Plasma
timeFrame: From Day 1 up to Day 25
measure: Fraction (percent) of Dose Excreted Unchanged in Urine of TRA
timeFrame: Pre dose up to Day 25
measure: Tmax of TRA in Whole blood and Plasma
timeFrame: From Day 1 up to Day 25
measure: Apparent Volume of Distribution (Based on the Terminal Phase) of TRA in Whole blood and Plasma
timeFrame: From Day 1 up to Day 25
measure: Amount of VX-993 and Metabolites, Expressed as a percent of TRA, in Plasma, Urine and Feces
timeFrame: From Day 1 up to Day 25
Secondary outcomes:
measure: Metabolite Profiling and Identification in Plasma, Urine, and Feces
timeFrame: From Day 1 up to Day 25
measure: Terminal Phase Rate Constant (λz) of VX-993 Metabolites in Plasma and Urine (if applicable)
timeFrame: From Day 1 up to Day 25
measure: Amount of radioactivity excreted (Ae) of VX-993 Metabolites in Urine and Feces
timeFrame: Pre dose up to Day 25
measure: AUC0-last of VX-993 Metabolites in Plasma
timeFrame: From Day 1 up to Day 25
measure: AUC0-inf of VX-993 Metabolites in Plasma
timeFrame: From Day 1 up to Day 25
measure: CL/F of VX-993 Metabolites in Plasma
timeFrame: From Day 1 up to Day 25
measure: CLr of VX-993 Metabolites in Urine
timeFrame: From Day 1 up to Day 25
measure: Cmax of VX-993 Metabolites in Plasma
timeFrame: From Day 1 up to Day 25
measure: Fraction (percent) of Dose Excreted Unchanged in Urine of VX-993 Metabolites
timeFrame: Pre dose up to Day 25
measure: Tmax of VX-993 Metabolites in Plasma
timeFrame: Day 1 up to Day 25
measure: Apparent Volume of Distribution (Based on the Terminal Phase) of VX-993 Metabolites in Plasma
timeFrame: Day 1 up to Day 25
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 35
measure: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
timeFrame: Pre-dose up to Day 35
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion - Lincoln
state: Nebraska
Study officials:
References: