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Inaxaplin for Liver Disease

Phase 1
Recruiting
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 up to 5 years
Awards & highlights

Summary

This trial will test how a new drug, Inaxaplin, is processed by the body and how safe it is in people with liver problems compared to healthy individuals.

Who is the study for?
This trial is for individuals with mild or moderate liver disease, as well as healthy participants matched to those with liver impairment. Specific eligibility criteria are not provided.
What is being tested?
The study focuses on understanding how the body processes Inaxaplin (IXP) in people with different levels of liver health and assessing its safety and tolerability.
What are the potential side effects?
While specific side effects are not listed, the trial will monitor how safe and tolerable IXP is for participants, which implies looking out for any adverse reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 IXP on Day 1.
Group II: Cohort 3: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single dose of IXP on Day 1.
Group III: Cohort 2: Matched Healthy ParticipantsExperimental Treatment1 Intervention
Healthy participants matched to Cohort 1 will receive a single dose of IXP on Day 1.
Group IV: Cohort 1: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single dose of IXP on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IXP
2023
Completed Phase 1
~20

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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
251 Previous Clinical Trials
32,824 Total Patients Enrolled
~27 spots leftby Mar 2025