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Group 1 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 32.0 kilogram per meter square (Kg/m^2)
A total body weight greater than (>) 50 kilogram (kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 6 and 10: pre-dose up to 24 hours
Awards & highlights

Study Summary

This trial tests the safety and effects of a drug on heart rhythm, how the body processes it, and how it affects the body.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 6 and 10: pre-dose up to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 6 and 10: pre-dose up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in QT interval corrected by Fridericia's formula (QTcF)
Secondary outcome measures
Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite
Change in Heart Rate (HR)
Change in PR interval, segment
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group 1Experimental Treatment3 Interventions
Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.
Group II: Group 2AActive Control3 Interventions
Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.
Group III: Group 2BActive Control3 Interventions
Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moxifloxacin Placebo
2012
Completed Phase 3
~1400
VX-548 Placebo
2023
Completed Phase 1
~80
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
241 Previous Clinical Trials
32,161 Total Patients Enrolled
13 Trials studying Pain
994 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.

Is the enrollment of individuals over 55 years old permissible in this trial?

"The age range for this research is 18-55 years old."

Answered by AI

Has Group 1 gained regulatory approval from the U.S. Food and Drug Administration?

"Since this is a Phase 1 trial, with limited data concerning its safety and efficacy, we at Power rate Group 1's security as a score of 1."

Answered by AI

Am I qualified to access the benefits of this experiment?

"Qualifying individuals must demonstrate symptoms of pain and be between the ages 18 and 55 in order to join this medical research. The trial is looking for approximately 72 participants."

Answered by AI

Is the recruitment process of this trial still underway?

"According to information presented on clinicaltrials.gov, recruitment for this medical study is ongoing and the trial was originally posted on April 12th 2023 with a recent update being made May 5th 2023."

Answered by AI

How many participants are being administered the treatment in this research endeavor?

"Yes, the information hosted on clinicaltrials.gov verifies that this research venture is actively seeking out participants. This trial was originally posted April 12th 2023 and has been revised as recently as May 5th 2023. 72 individuals are being sought from 2 distinct sites for enrollment in this study."

Answered by AI
~38 spots leftby Mar 2025