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ALG-097558 for Coronavirus

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

Normal hepatic function with no known or suspected hepatic impairment

Must not have

Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.

Grade ≥1 Hemoglobin

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 aims to study the effects of liver problems on how the body processes a drug called ALG-097558 when taken orally twice a day. The study will include participants with liver issues and those

Who is the study for?

This trial is for adults with moderate liver problems (hepatic impairment) and healthy adults with normal liver function. Participants should match in age, weight, and possibly gender. It's not clear what specific conditions exclude someone from this trial since the exclusion criteria are not provided.

What is being tested?

The study is testing ALG-097558, a drug given orally twice daily to see how different levels of liver health affect its presence in the blood over time. This non-randomized study involves both people with moderate liver issues and those without any.

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on pharmacokinetics (how the drug moves through the body), detailed side effects aren't listed here. Generally, Phase 1 trials look out for any adverse reactions ranging from mild to severe.

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.

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My liver functions normally.

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My BMI is between 17.5 and 40, and I weigh more than 50 kg (110 lb).

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I am not pregnant, as confirmed by a blood test.

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I have liver dysfunction not caused by an acute liver condition, confirmed by tests or scans.

Exclusion Criteria

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

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I have a history of heart rhythm problems or risk factors for severe arrhythmias.

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My hemoglobin level is at least at grade 1.

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I have severe fluid buildup in my abdomen.

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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 considered low.

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

Area under the concentration time curve [AUC]

C0 [predose]

Half-life [t1/2]

+3 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

2Treatment groups

Experimental Treatment

Group I: Subjects with Normal Hepatic FunctionExperimental Treatment1 Intervention

Subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group II: Subjects with Moderate Hepatic Impairment (Child-Pughs Class B)Experimental Treatment1 Intervention

Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

0 / 10Eligibility criteria met