drugset / Trial / NCT06698549
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function
Phase 1
Completed
12 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 severe renal impairment and subjects without renal 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 renal impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.
Timeline
- Start
- 2025-02-20
- Primary completion
- 2025-07-23
- Completion
- 2025-08-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALG-097558 | Unknown | 300 mg | Oral |