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.
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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.
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
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University of Miami, Miami, Florida, United States, 33136
Orlando Clinical Research Center, Orlando, Florida, United States, 32809
Genesis Clinical Trials, Tampa, Florida, United States, 33603
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 75 Years
ALL
Yes
Aligos Therapeutics,
2026-02