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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05518734
• Other study ID #: VX22-708-003
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2022
• Est. completion date: March 7, 2023

Study information

• Verified date: March 2023
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• VX-708
Solution for intravenous (IV) administration.
• Itraconazole
Solution for oral administration.
• Midazolam
Solution for oral administration.
• Placebo
Placebo matched to VX-708 for IV administration.

Locations

Country	Name	City	State
United States	Celerion - Tempe	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Part A: Continuous Pulse Oximetry Monitoring as assessed by oxygen saturation for Cohort A4		Pre-dose up to 6 hours Post-dose
Primary	Part A: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score Monitoring		Day 1 up to Day 30
Primary	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	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
Secondary	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
Secondary	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
Secondary	Part B: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score		Day 1 up to Day 30