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Cohort 1: Mild Hepatic 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 14: up to 24 hours post-dose

Awards & highlights

Study Summary

This trial tests a drug's safety and how it works in people with liver problems, compared to healthy people.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14: up to 24 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14: up to 24 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14: up to 24 hours post-dose for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Apparent Clearance of VX-548 (CL/F)

Apparent Volume of Distribution of VX-548 (Vz/F)

Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548

+4 more

Secondary outcome measures

Apparent Clearance of VX-548 Metabolite (CL/F)

Brain Diseases, Metabolic

Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548 Metabolite

+7 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4: Matched Healthy ParticipantsExperimental Treatment1 Intervention

Healthy participants matched to cohort 3 will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Group II: Cohort 3: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention

Participants will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Group III: Cohort 2: Matched Healthy ParticipantsExperimental Treatment1 Intervention

Healthy participants matched to cohort 1 will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Group IV: Cohort 1: Mild Hepatic ImpairmentExperimental Treatment1 Intervention

Participants will receive multiple doses of VX-548 every 12 hours (q12h) from Day 1 through Day 14.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX-548

2022

Completed Phase 3

~3500

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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

243 Previous Clinical Trials

32,351 Total Patients Enrolled

14 Trials studying Pain

1,054 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 of legal age admissible to this trial?

"The requirements of this medical trial state that individuals between the ages 18 and 75 are eligible to apply. Moreover, there are 71 separate trials dedicated to patients younger than eighteen while 247 other studies cater specifically to those over 65 years old."

Answered by AI

Is Cohort 1: Mild Hepatic Impairment a secure option for individuals?

"Our estimation of Cohort 1: Mild Hepatic Impairment's safety ranks at a score of 1 due to the limited data available from its Phase 1 trial, both regarding efficacy and security."

Answered by AI

Is enrollment open for this research program?

"According to the clinicaltrials.gov database, this clinical trial has resumed its search for eligible participants since October 14th 2022. The study's most recent edit was on November 2nd 2022."

Answered by AI

What are the eligibility requirements for participation in this clinical trial?

"This clinical trial is seeking 36 individuals with chronic pain, aged 18 to 75 years old. Cohorts 1 and 3 are looking for participants who have mild or moderate hepatic impairment - defined as Child-Pugh total score of 5 to 6 points (for cohort 1) and 7 to 9 points (for cohort 3). Additionally, those patients must present documented liver disease. On the other hand, cohorts 2 and 4 desire healthy volunteers that match in age, sex, and weight with their counterparts from cohorts 1 & 3 respectively."

Answered by AI

How many individuals are taking part in the clinical experiment?

"Affirmative. According to the clinicaltrials.gov website, this research project is actively seeking participants since it was first posted on October 14th 2022 and recently modified on November 2nd 2022. This trial necessitates 36 volunteers at two distinct medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment

2022. "Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05560464.