ALG-097558 for Kidney Failure

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Aligos Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have impaired kidney function, you must have been on stable medications for at least 28 days before the trial.

Eligibility Criteria

This trial is for adults with severe kidney failure and healthy individuals with normal kidney function, ideally matched by age, weight, and if possible, gender. Specific eligibility criteria are not provided but typically include factors like stable health status and no conflicting medications or conditions.

Inclusion Criteria

I am between 18 and 75 years old.

Exclusion Criteria

My hemoglobin is below 9 g/dL and I have kidney issues.

I do not have active Hepatitis A, B, C, E, HIV, or COVID-19.

I am on dialysis due to kidney problems.

I do not drink more than 14 (if woman) or 21 (if man) units of alcohol weekly.

My hemoglobin level is below 10 g/dL and my kidneys are functioning normally.

Participant Groups

The study is testing ALG-097558's behavior in the body (pharmacokinetics) when given orally twice a day to people with severe renal impairment compared to those without. It aims to understand how kidney function affects the drug's processing.

4Treatment groups

Experimental Treatment

Group I: Subjects with Severe Renal ImpairmentExperimental Treatment1 Intervention

Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group II: Subjects with Normal Renal FunctionExperimental Treatment1 Intervention

Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group III: Subjects with Moderate Renal Impairment (Optional)Experimental Treatment1 Intervention

Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group IV: Subjects with Mild Renal Impairment (Optional)Experimental Treatment1 Intervention

Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.