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NCT05078580 · ClinicalTrials.gov registry record · Phase 1
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.
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT05078580 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 38 participants.
The verdict
NCT05078580, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
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.
Interventions
- DRUG Iptacopan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-11-10 |
| Est. Completion | 2022-06-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05078580
The ClinicalTrials.gov registry entry for NCT05078580 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Iptacopan is the first listed.
NCT05078580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05078580 about?
NCT05078580 is a clinical study titled "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.". 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.
What is the current status of trial NCT05078580?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2021-11-10. Estimated completion is 2022-06-20.
What interventions are being tested in trial NCT05078580?
The interventions under investigation include: Iptacopan (DRUG).
Who is sponsoring clinical trial NCT05078580?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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