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

Vertex Pharmaceuticals Incorporated56 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

VanzacaftorDRUG

Tablets for oral administration.

Vanzacaftor PlaceboDRUG

Placebo for oral administration.

MoxifloxacinDRUG

Tablets for oral administration.

Moxifloxacin Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion - Tempe

Tempe, Arizona, United States