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NCT05026996 · ClinicalTrials.gov registry record · Phase 1

Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target

NCT05026996 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 17 participants.

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The verdict

NCT05026996, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

This was a Phase I, open-label, single-dose, parallel-group study in participants with mild hepatic impairment (HI) and healthy matched control participants with normal hepatic function designed to evaluate the PK of pelacarsen following a single 80 mg s.c. dose. Participants were matched by gender, age (±10 years), and body weight (±15%).

Interventions

  • DRUG Pelacarsen

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-11-23
Est. Completion 2022-10-19
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT05026996

The ClinicalTrials.gov registry entry for NCT05026996 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 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 Pelacarsen is the first listed.

NCT05026996 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05026996 about?

NCT05026996 is a clinical study titled "Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants". This was a Phase I, open-label, single-dose, parallel-group study in participants with mild hepatic impairment (HI) and healthy matched control participants with normal hepatic function designed to evaluate the PK of pelacarsen following a single 80 mg s.c. dose. Participants were matched by gender,...

What is the current status of trial NCT05026996?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-11-23. Estimated completion is 2022-10-19.

What interventions are being tested in trial NCT05026996?

The interventions under investigation include: Pelacarsen (DRUG).

Who is sponsoring clinical trial NCT05026996?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.