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Unknown

VX-548 for Pain

Phase 1
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m^2)
A total body weight greater than (>) 50 kilogram (kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to day 44
Awards & highlights

Study Summary

This trial tests how a drug affects people's bodies and if it is safe and tolerable.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to day 44
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 44 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-548 and its Metabolite
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Secondary outcome measures
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: VX-548Experimental Treatment1 Intervention
Participants will be randomized to receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration on the PK of VX 548. There will be a 14 day washout period between each dosing period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3500

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
240 Previous Clinical Trials
32,145 Total Patients Enrolled
13 Trials studying Pain
993 Patients Enrolled for Pain

Media Library

VX-548 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05851157 — Phase 1
Pain Research Study Groups: VX-548
Pain Clinical Trial 2023: VX-548 Highlights & Side Effects. Trial Name: NCT05851157 — Phase 1
VX-548 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05851157 — Phase 1

Frequently Asked Questions

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

What prerequisites do participants need to meet in order to join this medical research project?

"To be eligible for this study, individuals must experience pain and fall between 18 - 65 years of age. 72 people will ultimately take part in the project."

Answered by AI

Does the Food and Drug Administration recognize VX-548?

"The available evidence towards the safety of VX-548 lies primarily in preclinical and Phase 1 studies, thus it was assigned a score of 1."

Answered by AI

Can new participants still be enrolled in this research study?

"The registry hosted on clinicaltrials.gov indicates that this study is currently recruiting participants, having first been listed on May 3rd 2023 and most recently updated 29 days later."

Answered by AI

Does the eligibility criteria for this trial encompass individuals of all ages?

"The upper and lower limits of age for eligibility are 18 years old and 65 years young, respectively."

Answered by AI

How many participants are being recruited for this experiment?

"Affirmative. According to information displayed on clinicaltrials.gov, this medical trial is actively recruiting and seeking 72 volunteers from a single location. The first post was made on May 3rd, 2023 with the most recent being edited on May 29th of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
ICON Salt Lake City
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~40 spots leftby Mar 2025