CompletedPhase 1

An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants

United States56 participantsStarted 2023-04-26

Plain-language summary

The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.

Who can participate

Age range18 Years – 45 Years

SexALL

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Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive * Male and female participants of age 18 to 45 years, both inclusive * Serum potassium, calcium, and magnesium values within normal ranges Key Exclusion Criteria: * Median QTcF\>450 msec on triplicate 12-lead ECGs * History of conduction abnormalities 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 23

Trial details

NCT IDNCT05867147

SponsorVertex Pharmaceuticals Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-14

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