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Cohort 1: Severe Renal Impairment 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 23
Awards & highlights

Study Summary

This trial tests how well a new drug works and is tolerated in people with and without kidney problems.

Eligible Conditions
  • Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 23
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 23 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 Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Secondary outcome measures
Apparent Clearance of VX-548
Apparent Non-Renal Clearance of VX-548
Apparent Renal Clearance of VX-548 and its Metabolite (CLr)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Matched Healthy ParticipantsExperimental Treatment1 Intervention
Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.
Group II: Cohort 3: Moderate Renal ImpairmentExperimental Treatment1 Intervention
Participants will receive a single dose of VX-548 in a fasted state.
Group III: Cohort 2: Matched Healthy ParticipantsExperimental Treatment1 Intervention
Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.
Group IV: Cohort 1: Severe Renal ImpairmentExperimental Treatment1 Intervention
Participants will receive a single dose of VX-548 in a fasted state.
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
243 Previous Clinical Trials
32,349 Total Patients Enrolled
14 Trials studying Pain
1,052 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 Cohort 1: Severe Renal Impairment considered a safe option for patients?

"Setting Cohort 1: Severe Renal Impairment to a safety rating of 1, our team at Power is conservatively relying on limited data regarding its efficacy and safety due to it being an early-stage Phase 1 trial."

Answered by AI

Are geriatric patients being accepted for inclusion in this experiment?

"In order to be considered for this clinical trial, individuals must range between 18 and 75 years of age. Those above the upper threshold will find 404 other studies available to them, while those beneath the lower limit can choose from 83 different trials."

Answered by AI

How many participants are being selected to join the trial?

"That is correct. Clinicaltrials.gov contains information which demonstrates that this medical experiment, posted on February 1st 2023, is still actively recruiting participants in need of the treatment. The study requires 18 volunteers to be sourced from two different locations."

Answered by AI

Are there still opportunities to participate in this experiment?

"Affirmative. The clinical trial portal currently lists this medical study, which was initially posted on February 1st 2023, as actively seeking participants. Only 18 patients need to be recruited from two different sites."

Answered by AI

Do I qualify as a participant in this experiment?

"This clinical trial seeks 18 volunteers between the ages of 18 and 75 with chronic pain. Cohort 1 participants must have a body mass index (BMI) ranging from 18 to 38 kg/m^2, stable renal function for at least one month prior to enrollment, and meet other criteria set by the investigator. For Cohort 2, healthy matches will be found according to sex, age (+/- 10 years), and BMI (+/- 15%)."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Clinical Pharmacology of Miami, LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Aside from being healthy I do often have frequent body aches in most my body.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment
2023. "Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05704556.
~18 spots leftby Apr 2025
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