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Mezigdomide for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
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 up to 6 days
Awards & highlights

Study Summary

This trial tests how well a drug works in people with mild, moderate & severe liver problems compared to healthy people.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 days 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-time curve from time zero extrapolated to infinite time (AUC[INF])
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Maximum observed concentration (Cmax)
Secondary outcome measures
Metabolic ratio of AUC(0-INF)
Metabolic ratio of AUC(0-T)
Number of participants with adverse events (AEs)
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Severe hepatic impairmentExperimental Treatment1 Intervention
Group II: Moderate hepatic impairmentExperimental Treatment1 Intervention
Group III: Mild hepatic impairmentExperimental Treatment1 Intervention
Group IV: Healthy participantsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mezigdomide
2023
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,482 Total Patients Enrolled

Media Library

Mild hepatic impairment Clinical Trial Eligibility Overview. Trial Name: NCT05707390 — Phase 1
Liver Disease Research Study Groups: Mild hepatic impairment, Moderate hepatic impairment, Severe hepatic impairment, Healthy participants
Liver Disease Clinical Trial 2023: Mild hepatic impairment Highlights & Side Effects. Trial Name: NCT05707390 — Phase 1
Mild hepatic impairment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05707390 — Phase 1

Frequently Asked Questions

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

Are those below the age of 75 able to participate in this investigation?

"This clinical trial has set the minimum age of entry at 18 and capped the maximum age for enrollment at 75."

Answered by AI

What implications does Mild hepatic impairment have for human health?

"Our internal review at Power has assessed Mild hepatic impairment to have a safety rating of 1, as data for efficacy and safety is still being collected in clinical trials."

Answered by AI

Are individuals presently being recruited for this research endeavor?

"The most up-to-date information on clinicaltrials.gov indicates that this trial is not actively recruiting patients, despite being initially posted and last edited in February 2023. However, there are currently 250 other trials searching for participants across the globe."

Answered by AI

What criteria must be met in order for a person to participate in this clinical investigation?

"This medical experiment is enrolling 48 individuals with liver disorders, aged 18-75. In addition to this age requirement, participants must have mild (Group A), moderate (Group B) or severe (Group C) hepatic impairment as specified by the Child-Pugh Score and be free of any additional diseases that may interfere with the study evaluations. Furthermore, their laboratory test results for liver related issues need to fall within standard reference ranges or not deviate too far from such norms at the discretion of a qualified physician."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
PANAX
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
2023. "A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05707390.
~15 spots leftby Apr 2025
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