Pain
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.
Interventions
DRUGSuzetrigine
Tablets for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2) * Non-surgical participants with pain of new origin (not related to a prior known condition) that is moderate or severe on the verbal categorical rating scale (VRS) and ≥4 on the numeric pain rating scale (NPRS) * Surgical participants reporting pain at the surgical site that is moderate or severe on the VRS and ≥4 on the NPRS Key
Exclusion criteria
* Surgical participants: * History of previous surgery due to the same condition, except for procedures for which a previous surgery on the contra-lateral limb or organ is allowed * History of a prior surgical procedure in the same region of the body that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study * History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale | Day 14 or at Pain Resolution, whichever occurs first | The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 5-point Likert scale as: (poor, fair, good, very good or excellent). Percentage of participants who reported good, very good or excellent on the PGA scale was reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suzetrigine (SUZ) Participants received SUZ 100 mg as first dose, followed by SUZ 50 mg q12h for 14 days or until pain resolves, whichever occurs first. | 256 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrolled but not dosed | 2 |
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Withdrawal of consent (not due to AE) | 3 |
Baseline characteristics
| Characteristic | Suzetrigine (SUZ) |
|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 14.1 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 34 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 108 Participants |
| Race/Ethnicity, Customized Multiracial | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 148 Participants |
| Race/Ethnicity, Customized White | 214 Participants |
| Sex: Female, Male Female | 173 Participants |
| Sex: Female, Male Male | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 256 |
| other Total, other adverse events | 18 / 256 |
| serious Total, serious adverse events | 2 / 256 |
Outcome results
Primary
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 30
Population: Safety Set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suzetrigine (SUZ) | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with TEAEs | 94 Participants |
| Suzetrigine (SUZ) | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 2 Participants |
Secondary
Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale
The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 5-point Likert scale as: (poor, fair, good, very good or excellent). Percentage of participants who reported good, very good or excellent on the PGA scale was reported.
Time frame: Day 14 or at Pain Resolution, whichever occurs first
Population: Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suzetrigine (SUZ) | Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale | 83.2 percentage of participants |