RecruitingPhase 1NCT07283770

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 in Healthy Subjects


Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

128 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

  • Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
  • A total body weight of more than (>) 50 kg
  • Male and Female participants of non-childbearing potential

Exclusion Criteria2

  • 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

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Interventions

DRUGVX-581

Suspension for Oral Administration.

DRUGPlacebo

Suspension for Oral Administration.


Locations(1)

Altasciences - Kansas City

Overland Park, Kansas, United States

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NCT07283770


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