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NCT06568861 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
A Phase 1 study, sponsored by Aligos Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT06568861: Completed Phase 1 study, sponsored by Aligos Therapeutics.
NCT06568861 is a Phase 1 study that has completed, run by Aligos Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06568861, a Phase 1 study, has completed, sponsored by Aligos Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.
Primary Outcome
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Interventions
- DRUG ALG-097558
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-01-13 |
| Est. Completion | 2025-07-28 |
| Phase | Phase 1 |
What the finished NCT06568861 record still lists
NCT06568861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which ALG-097558 is the first listed.
NCT06568861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06568861 about?
NCT06568861 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function". This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characte...
What is the current status of trial NCT06568861?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-01-13. Estimated completion is 2025-07-28.
What interventions are being tested in trial NCT06568861?
The interventions under investigation include: ALG-097558 (DRUG).
Who is sponsoring clinical trial NCT06568861?
This trial is sponsored by Aligos Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06568861's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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