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A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine - Trial NCT06336096

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.

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NCT06336096
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06336096
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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

Study Focus

Pain

Suzetrigine

Interventional

drug

Sponsor & Location

Vertex Pharmaceuticals Incorporated

Tempe, United States of America

Timeline & Enrollment

Phase 1

Mar 28, 2024

Oct 01, 2024

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, unspecified
Pain, not elsewhere classified
Pain in limb
Acute pain
Other chronic pain

Data Source

ClinicalTrials.gov

NCT06336096

Non-Device Trial