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The purpose of this study is to determine the effects of Nav1.8 inhibition on activity-dependent slowing (ADS) of C-nociceptor nerve fibers, evoked action potential (AP) conduction velocity of C-nociceptor nerve fibers using VX-150, VX-993 and VX-548.
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 |
|---|---|---|---|
| VX-150 | Experimental | Participants will be randomized to receive a single dose of VX-150. |
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| VX-548 | Experimental | Participants will be randomized to receive a single dose of different dose levels of VX-548 |
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| VX-993 | Experimental | Participants will be randomized to receive a single dose of different dose levels of VX-993. |
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| Placebo | Placebo Comparator | Participants will receive single dose of non-matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-150 | Drug | Suspension for oral administration. |
| |
| VX-548 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Activity Dependent Slowing (ADS) Over Time | From Pre-dose up to 2-hours Post Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Conduction Velocity at 0.25 Hz Over Time | From Pre-dose up to 2-hours Post Dose | |
| Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time | From Pre-dose up to 2-hours Post Dose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
History of febrile illness or other acute illness that has not fully resolved within 14 days before study drug dosing
Any condition possibly affecting drug absorption
Any dermatological (generalized) or autoimmune disease that may affect C-nociceptor excitability
Participants with Type 1 or Type 2 diabetes mellitus
Participants who have any 1 of the following criteria in the foot in which microneurography (MNG) will be performed:
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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| Drug |
Solution or suspension for oral administration. |
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| VX-993 | Drug | Suspension for oral administration. |
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| Placebo | Drug | Suspension for oral administration. |
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| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | From Day 1 up to Day 16 |