A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults

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 doses of VX-973 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-973 in Healthy Adults

Conditions
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Pain

Intervention / Treatment
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* Drug: VX-973
* Drug: Placebo
* Drug: Midazolam


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 that has not fully resolved 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<br>Participants will be randomized to receive a single dose of VX-973 under fasted conditions. | Drug: VX-973<br>* Suspension for oral administration.<br>|
| Experimental: Part B: Multiple Ascending Dose<br>Participants will be randomized to receive multiple doses of VX-973 under fasted conditions. The dose and frequency will be determined based on Part A. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with study drug on Day 27. | Drug: VX-973<br>* Suspension for oral administration.<br>Drug: Midazolam<br>* Syrup for oral administration.<br>|
| Placebo Comparator: Placebo Part A<br>Participants will be randomized to receive placebo matched to VX-973. | Drug: Placebo<br>* Suspension for oral administration.<br>|
| Placebo Comparator: Placebo Part B<br>Participants will be randomized to receive placebo matched to VX-973. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with placebo matched to VX-973 on Day 27. | Drug: Placebo<br>* Suspension for oral administration.<br>Drug: Midazolam<br>* Syrup 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) |  | From Day 1 up to Day 31 | 
| Part 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 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973 |  | From Day 1 up to Day 30 | 
| Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973 |  | From Day 1 up to Day 43 | 
| Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973 |  | From Day 1 up to Day 30 | 
| Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973 |  | From Day 1 up to Day 43 | 
| Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-973 |  | Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose | 
| Part B: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-973 |  | Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose |