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Completed

NCT Number: NCT05518734

A Phase 1 Dose Escalation Study of VX-708 in Healthy Participants

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of VX-708 in healthy participants

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion - Tempe

Tempe, Arizona, 85283, United States

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-708

Drug

Solution for intravenous (IV) administration.

Itraconazole

Drug

Solution for oral administration.

midazolam

Drug

Solution for oral administration.

Placebo

Drug

Placebo matched to VX-708 for IV administration.

Primary outcomes

  1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Day 30

  2. Part A: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses

    Time frame: Day 1 up to Day 30

  3. Part A: Continuous Pulse Oximetry Monitoring as assessed by oxygen saturation for Cohort A4

    Time frame: Pre-dose up to 6 hours Post-dose

  4. Part A: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score Monitoring

    Time frame: Day 1 up to Day 30

  5. 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

    Time frame: Day 1 up to Day 16

Secondary outcomes

  1. Part A: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708

    Time frame: Day 1 up to Day 14

  2. 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)

    Time frame: Day 1 up to Day 14

  3. Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Day 32

  4. Part B: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score

    Time frame: Day 1 up to Day 30

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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