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Completed

NCT Number: NCT06886269

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

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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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion - Lincoln

Lincoln, Nebraska, 68502, United States

About this study

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.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

14C-VX-993

Drug

Solution for Oral Administration.

Primary outcomes

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

    Time frame: From Day 1 up to Day 25

  2. Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-993 in Plasma

    Time frame: From Day 1 up to Day 25

  3. Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 in Plasma

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 25

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

    Time frame: Pre dose up to Day 25

  10. AUC0-tlast of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 25

  11. AUC0-inf of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 25

  12. CL/F of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 25

  13. Renal Clearance (CLr) of TRA in Urine and Feces

    Time frame: Pre dose up to Day 25

  14. Cmax of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 25

  15. Fraction (percent) of Dose Excreted Unchanged in Urine of TRA

    Time frame: Pre dose up to Day 25

  16. Tmax of TRA in Whole blood and Plasma

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 25

Secondary outcomes

  1. Metabolite Profiling and Identification in Plasma, Urine, and Feces

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 25

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

    Time frame: Pre dose up to Day 25

  4. AUC0-last of VX-993 Metabolites in Plasma

    Time frame: From Day 1 up to Day 25

  5. AUC0-inf of VX-993 Metabolites in Plasma

    Time frame: From Day 1 up to Day 25

  6. CL/F of VX-993 Metabolites in Plasma

    Time frame: From Day 1 up to Day 25

  7. CLr of VX-993 Metabolites in Urine

    Time frame: From Day 1 up to Day 25

  8. Cmax of VX-993 Metabolites in Plasma

    Time frame: From Day 1 up to Day 25

  9. Fraction (percent) of Dose Excreted Unchanged in Urine of VX-993 Metabolites

    Time frame: Pre dose up to Day 25

  10. Tmax of VX-993 Metabolites in Plasma

    Time frame: Day 1 up to Day 25

  11. Apparent Volume of Distribution (Based on the Terminal Phase) of VX-993 Metabolites in Plasma

    Time frame: Day 1 up to Day 25

  12. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Day 35

  13. Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses

    Time frame: Pre-dose up to Day 35

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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