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Anti-epileptic agent

Part A for Pain

Phase 1

Recruiting

Research Sponsored by Vertex Pharmaceuticals Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A total body weight greater than 50 kilogram (kg)

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 up to day 43

Awards & highlights

Study Summary

This trial will study how the body processes a drug called suzetrigine and its byproduct in healthy individuals, focusing on its safety and how well it is tolerated.

Who is the study for?

This trial is for healthy individuals with a BMI of 18.0 to 32.0 kg/m^2 and weight over 50 kg who are not able to bear children. It's not suitable for those who've had a fever or acute illness within the last two weeks or have conditions that could affect drug absorption.Check my eligibility

What is being tested?

The study tests how the body absorbs Suzetrigine, its breakdown product, and their effects when taken with food in healthy people. It also looks at how safe and tolerable the drug is.See study design

What are the potential side effects?

While specific side effects aren't listed, generally such studies monitor for any adverse reactions including nausea, headaches, dizziness, allergic reactions or other unexpected health concerns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weigh more than 50 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 up to day 43

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 up to day 43

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 43 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

+3 more

Secondary outcome measures

Part A: AUC0-inf of SUZ Metabolite

Part A: AUC0-tlast of SUZ Metabolite

Part A: Cmax of SUZ Metabolite

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part CExperimental Treatment1 Intervention

Participants will be randomized to receive a single dose of a pre-determined strength of SUZ in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of two tablet formulations of SUZ. There will be a 14-day washout period between each dosing period.

Group II: Part BExperimental Treatment1 Intervention

Participants will be randomized to receive a single dose of SUZ formulation in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of tablet formulation compared to a suspension of SUZ. There will be a 14-day washout period between each dosing period.

Group III: Part AExperimental Treatment1 Intervention

Participants will be randomized to receive a single dose of SUZ in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two tablet formulations and the effect of food on the PK of SUZ. There will be a 14-day washout period between each dosing period.

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor

245 Previous Clinical Trials

32,470 Total Patients Enrolled

16 Trials studying Pain

1,170 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above 20 years of age eligible for enrollment in this trial?

"To be eligible for this research study, participants must fall between the ages of 18 and 55. It is worth noting that there are currently 65 trials dedicated to individuals under 18 years old and 279 studies focused on patients over the age of 65."

Answered by AI

What is the upper limit for the number of individuals participating in this medical research endeavor?

"Indeed, as per clinicaltrials.gov data, this investigation is actively pursuing suitable candidates. Initially uploaded on March 28th, 2024, the trial was last revised on April 24th of the same year. Enrollment aims to include 72 participants from a single site."

Answered by AI

Are there ongoing efforts to enroll participants in this medical study at the moment?

"Affirmative. Information on clinicaltrials.gov indicates that this trial is currently seeking participants. The study was first posted on March 28, 2024 and last revised on April 24, 2024. Enrollment is targeted at recruiting a total of 72 patients from one designated site."

Answered by AI

Has Part A obtained certification from the FDA?

"Our team at Power has assigned a rating of 1 to the safety of Part A, as this trial is in Phase 1 with restricted evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336096.

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