A Microneurography (MNG) Study of VX-150 in Healthy Participants

Pain Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effects of VX-150 on C-Nociceptor Action Potentials in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05418712
• Other study ID #: VX22-150-012
• Status: Completed
• Phase: Phase 1
• Start date: June 16, 2022
• Est. completion date: September 23, 2022

Study information

• Verified date: October 2022
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if C fiber conduction is impacted by NAV1.8 modulation.

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: 45
• Est. completion date: September 23, 2022
• Est. primary completion date: September 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2)

• A total body weight >50 kg

Key Exclusion Criteria:

• Participants who have any 1 of the following criteria in the foot/ankle in which MNG will be performed:

• Injection of local anesthetics or steroids within 35 days prior to randomization

• Unsuitable anatomy of the superficial peroneal nerve (i.e., nerve cannot be seen or palpated at the dorsum of the foot/ankle)

• Infection, disease (dermatologic or vascular), ongoing pain, or recent trauma or surgery that may affect study assessments

• History of febrile illness within 14 days before study drug dosing

• Any condition possibly affecting drug absorption

• Participants with Type 1 or Type 2 diabetes mellitus

• Any dermatological (generalized) or autoimmune disease that may affect C-nociceptor excitability

Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo
Placebo matched to VX-150 for oral administration.
• VX-150
Solution or Suspension for oral administration.

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Action Potential (AP) Latency at 0.25 Hertz (Hz) Over Time		From Baseline up to 3 Hours After Dose
Secondary	Change From Baseline in Percentage Slowing Over Time	Percentage slowing is measured by a relative change in latency from the start to the end of each activity-dependent slowing (ADS) stimulus train.	From Baseline up to 3 Hours After Dose
Secondary	Change From Baseline in the Time to Reverse 50 Percent (%) of the Activity-induced Latency Change After the End of Each ADS Stimulus Train Over Time		From Baseline up to 3 Hours After Dose
Secondary	Change From Baseline in the Percentage Recovery of the Activity-induced Latency Change at 30 Seconds After the End of Each ADS Stimulus Train Over Time		From Baseline up to 3 Hours After Dose
Secondary	Change From Baseline in Conduction Velocity at 0.25 Hz Over Time		From Baseline up to 3 Hours After Dose
Secondary	Change From Baseline in AP Amplitude at 0.25 Hz Over Time		From Baseline up to 3 Hours After Dose
Secondary	Change From Baseline in the Area Under the AP Peaks at 0.25 Hz Over Time		From Baseline up to 3 Hours After Dose
Secondary	Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)		Day 1 up to Day 10