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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

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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,953 Total Patients Enrolled
~10 spots leftby Jul 2025