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

NCT05867147 | Completed Phase 1 FDA Drug

• 1 other identifier: VX22-121-013
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in QT interval corrected by Fridericia's formula (QTcF)

  From Baseline up to Day 23

Secondary Outcomes (16)

• Change in Heart Rate (HR)

  From Baseline up to Day 23

• Change in PR interval, segment

  From Baseline up to Day 23

• Change in QRS duration

  From Baseline up to Day 23

• Placebo-corrected Change in QTcF

  From Baseline up to Day 23

• Placebo-corrected Change in HR

  From Baseline up to Day 23

Study Arms (3)

Group 1

EXPERIMENTAL

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

Drug: Vanzacaftor; Drug: Vanzacaftor Placebo; Drug: Moxifloxacin Placebo

Group 2A

ACTIVE COMPARATOR

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

Drug: Vanzacaftor Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo

Group 2B

ACTIVE COMPARATOR

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

Drug: Vanzacaftor Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo

Interventions

Vanzacaftor DRUG

Tablets for oral administration.

Group 1

Vanzacaftor Placebo DRUG

Placebo for oral administration.

Group 1; Group 2A; Group 2B

Moxifloxacin DRUG

Tablets for oral administration.

Group 2A; Group 2B

Moxifloxacin Placebo DRUG

Tablets for oral administration.

Group 1; Group 2A; Group 2B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Median QTcF\>450 msec on triplicate 12-lead ECGs
• History of conduction abnormalities

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Celerion - Tempe

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

deutivacaftor, tezacaftor , vanzacaftor; Moxifloxacin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 19, 2023
• Study Start: April 26, 2023
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)