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The purpose of the study is to evaluate the pharmacokinetics (PK) of Suzetrigine (SUZ) and its metabolite in the absence and presence of efavirenz, a moderate CYP3A inducer. In addition, the purpose is to evaluate the safety and tolerability of SUZ when administered in the absence and presence of efavirenz.
The study is being conducted to evaluate the effects of efavirenz on the PK of SUZ in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Participants will receive study medication for a duration of 30 days.
Note: 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 |
|---|---|---|---|
| SUZ and Efavirenz | Experimental | Participants will receive a single dose of SUZ on Days 1 through 15. Participants will also receive a single dose of SUZ in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzetrigine | Drug | Tablet for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of SUZ and its Metabolite in the Absence and Presence of Efavirenz | Day 15 and Day 30 | |
| Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCÏ„) of SUZ and its Metabolite in the Absence and Presence of Efavirenz | Day 15 and Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 46 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON - Utah - Salt Lake City Office | Salt Lake City | Utah | 84124 | United States |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-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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| ID | Term |
|---|---|
| C098320 | efavirenz |
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| Efavirenz | Drug | Tablet for oral administration. |
|