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Complement Inhibitor

Healthy participants for Liver Disease

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 day 1 (few time pints), day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 and day 11
Awards & highlights

Study Summary

This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (few time pints), day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 and day 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (few time pints), day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 and day 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic parameters of iptacopan: AUClast The AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time × volume-1)
Pharmacokinetic parameters of iptacopan: Cmax The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1)
Pharmacokinetics parameters of iptacopan: AUCinf The AUC from time zero to infinity (mass × time × volume-1)
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Severe hepatic impairment patientsExperimental Treatment1 Intervention
Iptacopan 200 mg single dose
Group II: Moderate hepatic impairment patientsExperimental Treatment1 Intervention
Iptacopan 200 mg single dose
Group III: Mild hepatic impairment patientsExperimental Treatment1 Intervention
Iptacopan 200 mg single dose
Group IV: Healthy participantsExperimental Treatment1 Intervention
Iptacopan 200 mg single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iptacopan
2021
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
4,198,206 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
2021. "Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05078580.
~11 spots leftby Apr 2025
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