A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.

Official Title
-----------------
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: VX-548
* Drug: HB/APAP
* Drug: Placebo (matched to VX-548)
* Drug: Placebo (matched to HB/APAP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Before Surgery: Participant scheduled to undergo an abdominoplasty without collateral procedures After Surgery: Participant is lucid and able to follow commands All analgesic guidelines were followed during and after the abdominoplasty Abdominoplasty procedure duration <=3 hours without collateral procedures (for example., liposuction) Key Exclusion Criteria Before Surgery: Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) Any prior surgery within 1 month before the first study drug After Surgery: Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization Participant had collateral procedures during the abdominoplasty Other protocol defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-548<br>Participants will be randomized to receive different dose levels of VX-548. | Drug: VX-548<br>* Tablets for oral administration.<br>Drug: Placebo (matched to HB/APAP)<br>* Placebo matched to HB/APAP for oral administration.<br>|
| Active Comparator: Hydrocodone bitartrate/ acetaminophen (HB/APAP)<br>Participants will receive HB/APAP. | Drug: HB/APAP<br>* Capsules for oral administration.<br>Drug: Placebo (matched to VX-548)<br>* Placebo matched to VX-548 for oral administration.<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebos matched to VX-548 and HB/APAP. | Drug: Placebo (matched to VX-548)<br>* Placebo matched to VX-548 for oral administration.<br>Drug: Placebo (matched to HB/APAP)<br>* Placebo matched to HB/APAP for oral administration.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug |  | 0 to 48 Hours After the First Dose of Study Drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug |  | 0 to 24 Hours After the First Dose of Study Drug | 
| Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug |  | At 48 Hours After the First Dose of Study Drug | 
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Day 17 |