Pain
Conditions
Brief summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of VX-708 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
DRUGVX-708
Solution for intravenous (IV) administration.
DRUGItraconazole
Solution for oral administration.
DRUGMidazolam
Solution for oral administration.
DRUGPlacebo
Placebo matched to VX-708 for IV administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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: * Male and female of non-childbearing potential are eligible * Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2) * A total body weight greater than (\>) 50 kg Key
Exclusion criteria
* History of febrile illness or other acute illness within 14 days before the first dose of study drug * History of cardiac dysrhythmias * Part A Cohorts with Midazolam DDI Evaluation (Cohort A4) Only * Hypersensitivity to midazolam or benzodiazepines * Part A Cohorts with CSF Sampling (Cohorts A2 and A3) Only * Hypersensitivity to local anesthetic for lumbar puncture * History of conditions leading to increased intracranial pressure (e.g., brain tumor, idiopathic intracranial hypertension, venous sinus thrombosis) * Part B Only * Hypersensitivity to itraconazole Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 30 |
| Part A: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 1 up to Day 30 |
| Part A: Continuous Pulse Oximetry Monitoring as assessed by oxygen saturation for Cohort A4 | Pre-dose up to 6 hours Post-dose |
| Part A: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score Monitoring | Day 1 up to Day 30 |
| Part B: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708 in the Absence or Presence of Itraconazole | Day 1 up to Day 16 |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708 | Day 1 up to Day 14 |
| Part A: Area Under the Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Midazolam and 1-hydroxy-midazolam in the Absence or Presence of VX-708 (Cohort A4) | Day 1 up to Day 14 |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 32 |
| Part B: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score | Day 1 up to Day 30 |
Countries
United States
Outcome results
None listed