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The purpose of this study is to determine if C fiber conduction is impacted by NAV1.8 modulation.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive placebo matched to VX-150. |
|
| VX-150 | Experimental | Participants will be randomized to receive a single dose of one of different dose levels VX-150. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo matched to VX-150 for oral administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Action Potential (AP) Latency at 0.25 Hertz (Hz) Over Time | From Baseline up to 3 Hours After Dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Participants who have any 1 of the following criteria in the foot/ankle in which MNG will be performed:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAC Clinical Research | Manchester | United Kingdom |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| VX-150 |
| Drug |
Solution or Suspension for oral administration. |
|
| 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 |