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NCT06336096Recruiting

A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine

A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of Suzetrigine in Healthy Adult Subjects
Vertex Pharmaceuticals IncorporatedPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pain
Drug/Device/Intervention
Suzetrigine
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Vertex Pharmaceuticals Incorporated
Location
Tempe, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Mar 28, 2024
End date
Oct 01, 2024
Enrollment
72 participants
Primary outcome

Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ,Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ,Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ,Part B: Cmax of SUZ,Part B: AUC0-tlast of SUZ,Part B: AUC0-inf of SUZ

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ;
 VX-548) and its metabolite along with its safety and tolerability, in healthy participants.

ICD-10 classifications
Pain, unspecifiedPain, not elsewhere classifiedPain in limbAcute painOther chronic pain
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06336096
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06336096 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vertex Pharmaceuticals Incorporated and is currently Recruiting. The study focuses on Pain. Target enrollment is 72 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.