MedTrace Logo

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.

NCT05078580 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-07-24

No results posted yet for this 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.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Iptacopan

Single oral dose of iptacopan 200 mg oral capsules

DRUG

Iptacopan

Single oral dose of iptacopan 200 mg oral capsules

DRUG

Iptacopan

Single oral dose of Iptacopan 200 mg oral capsules

DRUG

Iptacopan

Single oral dose of Iptacopan 200 mg oral capsules

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2022-06-20
Completion
2022-06-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078580 on ClinicalTrials.gov