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OpenTrials
Completed

NCT Number: NCT05867147

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

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.

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion - Tempe

Tempe, Arizona, 85283, United States

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vanzacaftor

Drug

Tablets for oral administration.

Vanzacaftor Placebo

Drug

Placebo for oral administration.

moxifloxacin

Drug

Tablets for oral administration.

Moxifloxacin Placebo

Drug

Tablets for oral administration.

Primary outcomes

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

    Time frame: From Baseline up to Day 23

Secondary outcomes

  1. Change in Heart Rate (HR)

    Time frame: From Baseline up to Day 23

  2. Change in PR interval, segment

    Time frame: From Baseline up to Day 23

  3. Change in QRS duration

    Time frame: From Baseline up to Day 23

  4. Placebo-corrected Change in QTcF

    Time frame: From Baseline up to Day 23

  5. Placebo-corrected Change in HR

    Time frame: From Baseline up to Day 23

  6. Placebo-corrected Change in PR interval

    Time frame: From Baseline up to Day 23

  7. Placebo-corrected Change in QRS duration

    Time frame: From Baseline up to Day 23

  8. Number of Outliers for QTcF

    Time frame: From Baseline up to Day 23

  9. Number of Outliers for HR

    Time frame: From Baseline up to Day 23

  10. Number of Outliers for PR interval

    Time frame: From Baseline up to Day 23

  11. Number of Outliers for QRS duration

    Time frame: From Baseline up to Day 23

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

    Time frame: From Baseline up to Day 23

  13. 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

  14. Maximum Observed Plasma Concentration (Cmax) of VNZ

    Time frame: Days 11 and 21

  15. 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

  16. Time Taken for VNZ to Reach Maximum Concentration (tmax)

    Time frame: Days 11 and 21

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 19, 2023
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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