A Phase 1 Dose Escalation Study of VX-993 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-993 at different doses in healthy participants.

Detailed Description
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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.).

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX-993 in Healthy Adults

Conditions
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Pain

Intervention / Treatment
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* Drug: VX-993
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2) A total body weight of more than (>) 50 kg Participants of non-childbearing potential Nonsmoker or ex-smoker for at least 3 months before screening Key Exclusion Criteria: History of febrile illness or other acute illness within 14 days before the first dose of study drug Any condition possibly affecting drug absorption Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Single Ascending Dose (SAD)<br>Participants will be randomized to receive a single dose of different dose levels of VX-993. | Drug: VX-993<br>* Suspension for oral administration.<br>|
| Experimental: Part B: Multiple Ascending Dose (MAD)<br>Participants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A. | Drug: VX-993<br>* Suspension for oral administration.<br>|
| Placebo Comparator: Placebo Part A<br>Participants will be randomized to receive placebo matched to VX-993. | Drug: Placebo<br>* Suspension for oral administration.<br>|
| Placebo Comparator: Placebo Part B<br>Participants will be randomized to receive multiple doses of placebo matched to VX-993. | Drug: Placebo<br>* Suspension for oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Day 25 | 
| Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Day 25 | 
| Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses |  | Pre-dose up to Day 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993 |  | Pre-dose up to Day 25 | 
| Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 |  | Pre-dose up to Day 25 | 
| Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993 |  | Pre-dose up to Day 25 | 
| Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 |  | Pre-dose up to Day 25 | 
| Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test |  | Day 1, Day 10, and Day 11 |