Clinical trial NCT05518734: A Phase 1 Dose Escalation Study of VX-708 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX-708 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-08-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.).

Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 30
measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
timeFrame: Day 1 up to Day 30
measure: Part A: Continuous Pulse Oximetry Monitoring as assessed by oxygen saturation for Cohort A4
timeFrame: Pre-dose up to 6 hours Post-dose
measure: Part A: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score Monitoring
timeFrame: Day 1 up to Day 30
measure: 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
timeFrame: Day 1 up to Day 16
Secondary outcomes:
measure: Part A: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708
timeFrame: Day 1 up to Day 14
measure: 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)
timeFrame: Day 1 up to Day 14
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 32
measure: Part B: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score
timeFrame: Day 1 up to Day 30
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion - Tempe
state: Arizona
Study officials:
References: