A Phase 1 Dose Escalation Study of Oral VX-708 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, and pharmacodynamics of single and multiple ascending doses of VX-708 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 Oral VX-708 in Healthy Subjects

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: VX-708
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male and female of non-childbearing potential are eligible Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m^2) A total body weight greater than (>) 50 kg 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, distribution, metabolism, or excretion History of cardiac dysrhythmias 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: VX-708<br>Participants will be randomized to receive a single dose of different dose levels of VX-708. | Drug: VX-708<br>* Solution or suspension for oral administration.<br>|
| Placebo Comparator: Part A: Placebo<br>Participants will receive placebo matched to VX-708. | Drug: Placebo<br>* Placebo matched to VX-708 for oral administration.<br>|
| Experimental: Part B: VX-708<br>Participants will be randomized to receive multiple doses of different dose levels of VX-708. The dose levels will be determined based on the data from Part A. | Drug: VX-708<br>* Solution or suspension for oral administration.<br>|
| Placebo Comparator: Part B: Placebo<br>Participants will receive placebo matched to VX-708. | Drug: Placebo<br>* Placebo matched to VX-708 for oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | From 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 |  | From Day 1 up to Day 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708 |  | From Day 1 up to Day 25 | 
| Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test |  | From Day 1 up to Day 11 |