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CFTR Modulator

Icenticaftor for Liver Failure

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, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Awards & highlights

Study Summary

This trial will test a new drug to see how well it works and how safe it is for people with different levels of liver damage.

Eligible Conditions
  • Liver Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 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 plasma clearance (CL/F) of icenticaftor after single oral dose
Apparent volume of distribution during terminal phase (Vz/F) of icenticaftor after single oral dose
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of icenticaftor after single oral dose
+4 more
Secondary outcome measures
AUCinf of unbound icenticaftor (AUCinf,u)
AUClast of unbound icenticaftor (AUClast,u)
CL/F of unbound icenticaftor (CL/F,u)
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4 - Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Severe hepatic impairment: Child-Pugh C (Score 10-15)
Group II: Group 3 - Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Moderate hepatic impairment: Child-Pugh B (Score 7-9)
Group III: Group 2 - Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Mild hepatic impairment: Child-Pugh A (Score 5-6)
Group IV: Group 1 - Healthy subjects with normal hepatic functionExperimental Treatment1 Intervention
Healthy subjects with normal hepatic function - Control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icenticaftor
2020
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?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,204 Total Patients Enrolled
1 Trials studying Liver Failure
34 Patients Enrolled for Liver Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
2020. "Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04587622.
~9 spots leftby Apr 2025
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