Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants.
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.).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Participants will be randomized to receive a single dose of SUZ in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two tablet formulations and the effect of food on the PK of SUZ. There will be a 14-day washout period between each dosing period. |
|
| Part B | Experimental | Participants will be randomized to receive a single dose of SUZ formulation in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of tablet formulation compared to a suspension of SUZ. There will be a 14-day washout period between each dosing period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzetrigine | Drug | Tablet(s) for oral administration. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ | Pre-dose up to Day 43 | |
| Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ | Pre-dose up to Day 43 | |
| Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ | Pre-dose up to Day 43 | |
| Part B: Cmax of SUZ | Pre-dose up to Day 29 | |
| Part B: AUC0-tlast of SUZ | Pre-dose up to Day 29 | |
| Part B: AUC0-inf of SUZ | Pre-dose up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Cmax of SUZ Metabolite | Pre-dose up to Day 43 | |
| Part A: AUC0-tlast of SUZ Metabolite | Pre-dose up to Day 43 | |
| Part A: AUC0-inf of SUZ Metabolite |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion - Tempe | Tempe | Arizona | 85283 | United States |
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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Suzetrigine | Drug | Tablet(s) and Suspension for oral administration. |
|
|
| Pre-dose up to Day 43 |
| Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 43 |
| Part B: Cmax of SUZ Metabolite | Pre-dose up to Day 29 |
| Part B: AUC0-tlast of SUZ Metabolite | Pre-dose up to Day 29 |
| Part B: AUC0-inf of SUZ Metabolite | Pre-dose up to Day 29 |
| Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs | From Day 1 up to Day 29 |