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 Details — Status: Completed

Administrative data

• NCT number: NCT05867147
• Other study ID #: VX22-121-013
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2023
• Est. completion date: June 14, 2023

Study information

• Verified date: July 2023
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• Vanzacaftor
Tablets for oral administration.
• Vanzacaftor Placebo
Placebo for oral administration.
• Moxifloxacin
Tablets for oral administration.
• Moxifloxacin Placebo
Tablets for oral administration.

Locations

Country	Name	City	State
United States	Celerion - Tempe	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QT interval corrected by Fridericia's formula (QTcF)		From Baseline up to Day 23
Secondary	Change in Heart Rate (HR)		From Baseline up to Day 23
Secondary	Change in PR interval, segment		From Baseline up to Day 23
Secondary	Change in QRS duration		From Baseline up to Day 23
Secondary	Placebo-corrected Change in QTcF		From Baseline up to Day 23
Secondary	Placebo-corrected Change in HR		From Baseline up to Day 23
Secondary	Placebo-corrected Change in PR interval		From Baseline up to Day 23
Secondary	Placebo-corrected Change in QRS duration		From Baseline up to Day 23
Secondary	Number of Outliers for QTcF		From Baseline up to Day 23
Secondary	Number of Outliers for HR		From Baseline up to Day 23
Secondary	Number of Outliers for PR interval		From Baseline up to Day 23
Secondary	Number of Outliers for QRS duration		From Baseline up to Day 23
Secondary	Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence		From Baseline up to Day 23
Secondary	Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		From Day -2 up to Day 38
Secondary	Maximum Observed Plasma Concentration (Cmax) of VNZ		Days 11 and 21
Secondary	Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ		Days 11 and 21
Secondary	Time Taken for VNZ to Reach Maximum Concentration (tmax)		Days 11 and 21