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Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
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 pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, FIA586, in people with mild to moderate liver problems and healthy individuals. Researchers want to see how the drug moves through the body and how the liver processes it. This will help determine if people with liver issues need different dosages.

Eligible Conditions
  • Liver disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent Clearance (CL/F) of FIA586
Apparent volume of distribution during terminal elimination phase (Vz/F) of FIA586
Area Under Plasma Concentration-time Curve from Time Zero Extrapolated to Infinity (AUC[0-inf]) for FIA586
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3: Participants with moderate hepatic impairmentExperimental Treatment1 Intervention
Each participant will receive a single dose of FIA586
Group II: Group 2: Participants with mild hepatic impairmentExperimental Treatment1 Intervention
Each participant will receive a single dose of FIA586
Group III: Group 1: Healthy participants with normal hepatic functionExperimental Treatment1 Intervention
Each participant will receive a single dose of FIA586
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FIA586
2021
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,799 Total Patients Enrolled
~13 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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