A Phase 1 Dose Escalation Study of VX-708 in Healthy Participants
- Conditions
- Pain
- Interventions
- Registration Number
- NCT05518734
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: VX-708 (Cohort A1-A3) VX-708 Participants will receive multiple doses of one of different dose levels of VX-708 under fasting condition. Part A: Placebo Placebo Participants will receive placebo matched to VX-708. Part A: Midazolam With or Without VX-708 (Cohort A4) Midazolam Participants will receive a single dose of Midazolam with or without VX-708 under fasting condition. Part A: Midazolam With or Without VX-708 (Cohort A4) VX-708 Participants will receive a single dose of Midazolam with or without VX-708 under fasting condition. Part B: VX-708 With Itraconazole VX-708 Participants will receive a single dose of VX-708 in treatment period 1, followed by itraconazole, which will be dosed daily with a single dose of VX-708 administered in treatment period 2 under fasting conditions. A washout period of 6 days will be maintained between the 2 treatment periods. Part B: VX-708 With Itraconazole Itraconazole Participants will receive a single dose of VX-708 in treatment period 1, followed by itraconazole, which will be dosed daily with a single dose of VX-708 administered in treatment period 2 under fasting conditions. A washout period of 6 days will be maintained between the 2 treatment periods.
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method 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 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: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score Day 1 up to Day 30 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
Trial Locations
- Locations (1)
Celerion - Tempe
🇺🇸Tempe, Arizona, United States