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

Cystic Fibrosis Clinical Trial

Official title:
A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, Thorough QT/QTc Study of Vanzacaftor Monotherapy in Healthy Subjects

Clinical Trial 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.

Clinical Trial 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.). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05867147
Study type Interventional
Source Vertex Pharmaceuticals Incorporated
Contact
Status Completed
Phase Phase 1
Start date April 26, 2023
Completion date June 14, 2023
View Details
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