Pain
Conditions
Brief summary
The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.
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
DRUGVX-548
Tablets for oral administration.
DRUGMoxifloxacin
Capsules for oral administration.
DRUGMoxifloxacin Placebo
Capsules for oral administration.
DRUGVX-548 Placebo
Tablets for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 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) * A total body weight greater than (\>) 50 kilogram (kg) Key
Exclusion criteria
* History of febrile illness within 5 days before the first dose of study drug * Any condition possibly affecting drug absorption * Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones 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 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in PR interval, segment | From Baseline up to Day 12 |
| Change in QRS duration | From Baseline up to Day 12 |
| Placebo-corrected Change in QTcF | From Baseline up to Day 12 |
| Placebo-corrected Change in HR | From Baseline up to Day 12 |
| Placebo-corrected Change in PR interval | From Baseline up to Day 12 |
| Placebo-corrected Change in QRS duration | From Baseline up to Day 12 |
| Number of Outliers for QTcF | From Baseline up to Day 12 |
| Change in Heart Rate (HR) | From Baseline up to Day 12 |
| Number of Outliers for PR interval | From Baseline up to Day 12 |
| Number of Outliers for QRS duration | From Baseline up to Day 12 |
| Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence | From Baseline up to Day 12 |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 26 |
| Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite | Days 6 and 10: Pre-dose up to 24 hours |
| Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite | Days 6 and 10: Pre-dose up to 24 hours |
| Number of Outliers for HR | From Baseline up to Day 12 |
Countries
United States
Outcome results
None listed