CompletedPhase 1

A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants

United States72 participantsStarted 2023-04-12

Plain-language summary

The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2) * A total body weight greater than (\>) 50 kilogram (kg) Key Exclusion Criteria: * History of febrile illness within 5 days before the first dose of study drug * Any condition possibly affecting drug absorption * Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones Other protocol defined Inclusion/Exclusion criteria may apply.

What they're measuring

Change in QT interval corrected by Fridericia's formula (QTcF)

Timeframe: From Baseline up to Day 12

Trial details

NCT IDNCT05818852

SponsorVertex Pharmaceuticals Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-12

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