Clinical trial NCT05867147: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-05-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in QT interval corrected by Fridericia's formula (QTcF)
timeFrame: From Baseline up to Day 23
Secondary outcomes:
measure: Change in Heart Rate (HR)
timeFrame: From Baseline up to Day 23
measure: Change in PR interval, segment
timeFrame: From Baseline up to Day 23
measure: Change in QRS duration
timeFrame: From Baseline up to Day 23
measure: Placebo-corrected Change in QTcF
timeFrame: From Baseline up to Day 23
measure: Placebo-corrected Change in HR
timeFrame: From Baseline up to Day 23
measure: Placebo-corrected Change in PR interval
timeFrame: From Baseline up to Day 23
measure: Placebo-corrected Change in QRS duration
timeFrame: From Baseline up to Day 23
measure: Number of Outliers for QTcF
timeFrame: From Baseline up to Day 23
measure: Number of Outliers for HR
timeFrame: From Baseline up to Day 23
measure: Number of Outliers for PR interval
timeFrame: From Baseline up to Day 23
measure: Number of Outliers for QRS duration
timeFrame: From Baseline up to Day 23
measure: Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence
timeFrame: From Baseline up to Day 23
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day -2 up to Day 38
measure: Maximum Observed Plasma Concentration (Cmax) of VNZ
timeFrame: Days 11 and 21
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ
timeFrame: Days 11 and 21
measure: Time Taken for VNZ to Reach Maximum Concentration (tmax)
timeFrame: Days 11 and 21
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion - Tempe
state: Arizona
Study officials:
References: