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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: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT05026996 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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%).
Primary Outcome
The maximum (peak) observed drug concentration in after single-dose administration (mass x volume-1). To assess the PK properties of plasma pelacarsen after a single s.c. injection in participants with mild HI (Child-Pugh classification) as compared to matched healthy participants with normal hepatic function.
Interventions
- DRUG Pelacarsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2022-10-19 |
| Phase | Phase 1 |
What the finished NCT05026996 record still lists
NCT05026996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Pelacarsen is the first listed.
NCT05026996 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05026996's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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