drugset / Trial / NCT06568861
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
Phase 1
Completed
16 enrolled
Aligos Therapeutics
National Institute of Allergy and Infectious Diseases (NIAID) · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-01-13
- Primary completion
- 2025-07-16
- Completion
- 2025-07-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALG-097558 | Unknown | 200 mg | Oral |