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

Sponsor

Vertex Pharmaceuticals Incorporated (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05418712

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Days)

85.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Placebo Drug: VX-150	Phase 1

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.).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive placebo matched to VX-150.	Drug: Placebo Placebo matched to VX-150 for oral administration.
Experimental: VX-150 Participants will be randomized to receive a single dose of one of different dose levels VX-150.	Drug: VX-150 Solution or Suspension for oral administration.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Participants will receive placebo matched to VX-150.

Drug: Placebo

Placebo matched to VX-150 for oral administration.

Experimental: VX-150

Participants will be randomized to receive a single dose of one of different dose levels VX-150.

Drug: VX-150

Solution or Suspension for oral administration.

Outcome Measures

Primary Outcome Measures

Change From Baseline in Action Potential (AP) Latency at 0.25 Hertz (Hz) Over Time [From Baseline up to 3 Hours After Dose]

Secondary Outcome Measures

Change From Baseline in Percentage Slowing Over Time [From Baseline up to 3 Hours After Dose]
Percentage slowing is measured by a relative change in latency from the start to the end of each activity-dependent slowing (ADS) stimulus train.
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]
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]
Change From Baseline in Conduction Velocity at 0.25 Hz Over Time [From Baseline up to 3 Hours After Dose]
Change From Baseline in AP Amplitude at 0.25 Hz Over Time [From Baseline up to 3 Hours After Dose]
Change From Baseline in the Area Under the AP Peaks at 0.25 Hz Over Time [From Baseline up to 3 Hours After Dose]
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) [Day 1 up to Day 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

Body mass index (BMI) of 18.0 to 35.0 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MAC Clinical Research	Manchester		United Kingdom

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vertex Pharmaceuticals Incorporated

ClinicalTrials.gov Identifier:

NCT05418712

Other Study ID Numbers:

VX22-150-012

First Posted:

Jun 14, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 19, 2022