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ALG-097558 for Kidney Failure

Phase 1

Waitlist Available

Research Sponsored by Aligos Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and Female between 18 and 75 years old

Be older than 18 years old

Must not have

Hemoglobin <9 g/dL (for subjects with impaired renal function)

Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose (-0.75 hours) up to day 8

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called ALG-097558 in two groups of people: one with severe kidney problems and one with normal kidney function. The main goal is to see how the medication

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on pharmacokinetics, safety, and tolerability of ALG-097558, potential side effects are being investigated but are not specified here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am on dialysis due to kidney problems.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose (-0.75 hours) up to day 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose (-0.75 hours) up to day 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose (-0.75 hours) up to day 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apparent Clearance (CL/F)

Apparent Volume of Distribution (V/F)

Area under the concentration time curve [AUC]

+7 more

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met