NCT05867147

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Vanzacaftor	Tablets for oral administration.
DRUG	Vanzacaftor Placebo	Placebo for oral administration.
DRUG	Moxifloxacin	Tablets for oral administration.
DRUG	Moxifloxacin Placebo	Tablets for oral administration.

Timeline

• Start date: 2023-04-26
• Primary completion: 2023-06-14
• Completion: 2023-06-14
• First posted: 2023-05-19
• Last updated: 2023-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study