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

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vanzacaftor

Vanzacaftor Placebo

Moxifloxacin

Moxifloxacin Placebo

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Celerion - Tempe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2A

Group 2B

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Heart Rate (HR)

Change in PR interval, segment

Change in QRS duration

Placebo-corrected Change in QTcF

Placebo-corrected Change in HR

Placebo-corrected Change in PR interval

Placebo-corrected Change in QRS duration

Number of Outliers for QTcF

Number of Outliers for HR

Number of Outliers for PR interval

Number of Outliers for QRS duration

Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Maximum Observed Plasma Concentration (Cmax) of VNZ

Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ

Time Taken for VNZ to Reach Maximum Concentration (tmax)

Full Information

NCT ID

NCT05867147

First Posted

April 21, 2023

Last Updated

July 13, 2023

Sponsor

Vertex Pharmaceuticals Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT05867147

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

April 26, 2023 (Actual)

Primary Completion Date

June 14, 2023 (Actual)

Study Completion Date

June 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vertex Pharmaceuticals Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 2B

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vanzacaftor

Intervention Description

Tablets for oral administration.

Intervention Type

Drug

Intervention Name(s)

Vanzacaftor Placebo

Intervention Description

Placebo for oral administration.

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Intervention Description

Tablets for oral administration.

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin Placebo

Intervention Description

Tablets for oral administration.

Primary Outcome Measure Information:

Title

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

Time Frame

From Baseline up to Day 23

Secondary Outcome Measure Information:

Title

Change in Heart Rate (HR)

Time Frame

From Baseline up to Day 23

Title

Change in PR interval, segment

Time Frame

From Baseline up to Day 23

Title

Change in QRS duration

Time Frame

From Baseline up to Day 23

Title

Placebo-corrected Change in QTcF

Time Frame

From Baseline up to Day 23

Title

Placebo-corrected Change in HR

Time Frame

From Baseline up to Day 23

Title

Placebo-corrected Change in PR interval

Time Frame

From Baseline up to Day 23

Title

Placebo-corrected Change in QRS duration

Time Frame

From Baseline up to Day 23

Title

Number of Outliers for QTcF

Time Frame

From Baseline up to Day 23

Title

Number of Outliers for HR

Time Frame

From Baseline up to Day 23

Title

Number of Outliers for PR interval

Time Frame

From Baseline up to Day 23

Title

Number of Outliers for QRS duration

Time Frame

From Baseline up to Day 23

Title

Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence

Time Frame

From Baseline up to Day 23

Title

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame

From Day -2 up to Day 38

Title

Maximum Observed Plasma Concentration (Cmax) of VNZ

Time Frame

Days 11 and 21

Title

Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ

Time Frame

Days 11 and 21

Title

Time Taken for VNZ to Reach Maximum Concentration (tmax)

Time Frame

Days 11 and 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Celerion - Tempe

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Learn more about this trial

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

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