Cystic Fibrosis
Conditions
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.).
Interventions
DRUGVanzacaftor
Tablets for oral administration.
DRUGVanzacaftor Placebo
Placebo for oral administration.
DRUGMoxifloxacin
Tablets for oral administration.
DRUGMoxifloxacin Placebo
Tablets for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in QT interval corrected by Fridericia's formula (QTcF) | From Baseline up to Day 23 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Placebo-corrected Change in PR interval | From Baseline up to Day 23 |
| Placebo-corrected Change in QRS duration | From Baseline up to Day 23 |
| Number of Outliers for QTcF | From Baseline up to Day 23 |
| Change in Heart Rate (HR) | From Baseline up to Day 23 |
| Number of Outliers for PR interval | From Baseline up to Day 23 |
| Number of Outliers for QRS duration | From Baseline up to Day 23 |
| Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence | From Baseline up to Day 23 |
| 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 |
| Maximum Observed Plasma Concentration (Cmax) of VNZ | Days 11 and 21 |
| Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ | Days 11 and 21 |
| Time Taken for VNZ to Reach Maximum Concentration (tmax) | Days 11 and 21 |
| Number of Outliers for HR | From Baseline up to Day 23 |
Countries
United States
Outcome results
None listed