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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2023-06-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects

NCT01461460

Healthy Volunteer

COMPLETED PHASE1

A Study in Healthy Volunteers to Assess the Effect of Fedovapagon on the QT/QTC Interval

NCT02537288

Healthy

COMPLETED PHASE1

A Cardiac Liability Study of Varegacestat in Healthy Participants

NCT06855264

Healthy Volunteer

COMPLETED PHASE1

Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects

NCT00316459

Healthy Long QT Syndrome

COMPLETED PHASE1

A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)

NCT03606057

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points.

Group Type EXPERIMENTAL

Vanzacaftor

Intervention Type DRUG

Tablets for oral administration.

Vanzacaftor Placebo

Intervention Type DRUG

Placebo for oral administration.

Moxifloxacin Placebo

Intervention Type DRUG

Tablets for oral administration.

Group 2A

Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points.

Group Type ACTIVE_COMPARATOR

Vanzacaftor Placebo

Intervention Type DRUG

Placebo for oral administration.

Moxifloxacin

Intervention Type DRUG

Tablets for oral administration.

Moxifloxacin Placebo

Intervention Type DRUG

Tablets for oral administration.

Group 2B

Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.

Group Type ACTIVE_COMPARATOR

Vanzacaftor Placebo

Intervention Type DRUG

Placebo for oral administration.

Moxifloxacin

Intervention Type DRUG

Tablets for oral administration.

Moxifloxacin Placebo

Intervention Type DRUG

Tablets for oral administration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vanzacaftor

Tablets for oral administration.

Intervention Type DRUG

Vanzacaftor Placebo

Placebo for oral administration.

Intervention Type DRUG

Moxifloxacin

Tablets for oral administration.

Intervention Type DRUG

Moxifloxacin Placebo

Tablets for oral administration.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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