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Group 1 for Pain

ICON Lenexa, Lenexa, KS
PainVX-548 - Drug
Eligibility
18 - 55
All Sexes

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.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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1
Part A
1
Group 1
1
Treatment A

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Days 6 and 10: Pre-dose up to 24 hours

Day 6
Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Day 12
Change in Heart Rate (HR)
Change in PR interval, segment
Change in QRS duration
Change in QT interval corrected by Fridericia's formula (QTcF)
Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence
Number of Outliers for HR
Number of Outliers for PR interval
Number of Outliers for QRS duration
Number of Outliers for QTcF
Placebo-corrected Change in HR
Placebo-corrected Change in PR interval
Placebo-corrected Change in QRS duration
Placebo-corrected Change in QTcF
Day 26
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Safety

Phase-Based Safety

1 of 3

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1
Part A
1
Group 1
1
Treatment A

Trial Design

3 Treatment Groups

Group 2B
1 of 3
Group 2A
1 of 3
Group 1
1 of 3

Active Control

Experimental Treatment

72 Total Participants · 3 Treatment Groups

Primary Treatment: Group 1 · Has Placebo Group · Phase 1

Group 1Experimental Group · 3 Interventions: VX-548, VX-548 Placebo, Moxifloxacin Placebo · Intervention Types: Drug, Drug, Drug
Group 2BActiveComparator Group · 3 Interventions: VX-548 Placebo, Moxifloxacin Placebo, Moxifloxacin · Intervention Types: Drug, Drug, Drug
Group 2AActiveComparator Group · 3 Interventions: VX-548 Placebo, Moxifloxacin Placebo, Moxifloxacin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2021
Completed Phase 2
~610
Moxifloxacin Placebo
2011
Completed Phase 3
~1160

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 6 and 10: pre-dose up to 24 hours

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
231 Previous Clinical Trials
31,224 Total Patients Enrolled
11 Trials studying Pain
764 Patients Enrolled for Pain

Eligibility Criteria

Age 18 - 55 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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