Official Title
A Phase 1 Non-Randomized, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Renal Impairment and in Healthy Subjects with Normal Renal Function
Brief Summary

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study ofALG-097558 in subjects with severe renal impairment and subjects without renalimpairment, matched for age, body weight and, to the extent possible, for gender. Theprimary purpose of this study is to characterize the effect of renal impairment on theplasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily(Q12H) oral (PO) doses.

Detailed Description

Not Provided

Recruiting
COVID 19

Drug: ALG-097558

Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)

Eligibility Criteria

Inclusion Criteria for All Subjects:

1. Male and Female between 18 and 75 years old

2. Body Mass Index (BMI) 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)

3. Female subjects must either be not of childbearing potential or if they are a woman
of childbearing potential, they are only eligible if they and any non-sterile, male
sexual partners agree to use highly effective contraceptive therapy

Inclusion Criteria for Subjects with Normal Renal Function:

1. Good general health as defined by no clinically relevant abnormalities identified by
Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram
(ECG) assessment

2. Subjects must fit the demographic-matching criteria including body weight, age, and
to the extent possible, gender

3. Normal renal function (estimated Glomerular Filtration Rate [eGFR] ≥90 mL/min) with
no known or suspected renal impairment

Inclusion Criteria for Subjects with Impaired Renal Function:

1. Subject satisfies the eGFR criteria for renal impairment classification within 28
days of study drug administration

2. Any form of renal impairment except acute nephritic syndrome (subjects with history
of previous nephritic syndrome but in remission can be included).

3. Stable concomitant medications for the management of an individual subject's medical
history for at least 28 days prior to screening

4. Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol
criteria

Exclusion Criteria for All Subjects:

1. Subjects with any current or previous illness that, in the opinion of the
Investigator, might confound the results of the study or pose an additional risk in
administering study drug to the subject or that could prevent, limit, or confound
the protocol specified assessments or study results and interpretation

2. 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 (subjects with normal renal
function) or unstable (subjects with renal impairment) cardiac disease etc.

3. Subjects with a history of clinically significant drug allergy

4. Subjects with a recent (within 1 year of randomization) history or current evidence
of drug abuse or recreational drug use

5. Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women
and ≥21 units/week for men

6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study
through end of study follow up

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

8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
values >2x upper limit of normal (ULN)

9. Subjects with bilirubin (total, direct) >1.5x ULN (unless Gilbert's is suspected)

10. Positive pregnancy test; females must not be pregnant at enrollment

Exclusion Criteria for Subjects with Normal Renal Function:

1. Hemoglobin <10 g/dL

Exclusion Criteria for Subjects with Impaired Renal Function:

1. Participants requiring hemodialysis and/or peritoneal dialysis

2. Hemoglobin <9 g/dL

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
United States
Locations

University of Miami
Miami, Florida, United States

Orlando Clinical Research Center
Orlando, Florida, United States

Genesis Clinical Trials
Tampa, Florida, United States

Contacts

Jen Rito
(800) 466-6059
info@aligos.com

Not Provided

National Institute of Allergy and Infectious Diseases (NIAID)
NCT Number
MeSH Terms
Renal Insufficiency