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This is a randomized, double-blind, placebo-controlled within-participant crossover study in healthy male participants 18-55 years of age to assess pain tolerance during a cold pressor test.
The study will be conducted at a single center in New Zealand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Schedule A | Other | participants receive suzetrigine 100mg in treatment period 1, and receive placebo in treatment period 2 |
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| Schedule B | Other | participants receive placebo in treatment period 1, and receive suzetrigine 100mg in treatment period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suzetrigine 100mg | Drug | Suzetrigine is an inhibitor of the NaV1.8 voltage-gated sodium channel and FDA approved for the treatment of moderate-to-severe acute pain in adults |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline pain score after dosing with suzetrigine vs. placebo | Numerical Pain Rating Scale (NPRS) will be assessed during Cold Pressor Tests at various time points for time to reach Pain Detection Threshold (PDT) and time to reach Pain Tolerance Threshold (PTT) | 0-24 hours during each treatment period |
| Time to reach Pain Detection Threshold (PDT) and Pain Tolerance Threshold (PTT) after dosing with suzetrigine vs placebo | Stopwatches will be used during each cold pressor test to determine time for subject to reach PDT and PTT | 0-24 hours during each treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research, Christchurch | Christchurch | New Zealand |
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| Placebo | Other | biologically inactive placebo comparator |
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