A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
- Conditions
- COVID-19
- Registration Number
- NCT06568861
- Lead Sponsor
- Aligos Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria for All Subjects:<br><br> 1. Male and Female between 18 and 75 years old<br><br> 2. BMI 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb) 3 .Female subjects<br> must either be not of childbearing potential or if they are a woman of childbearing<br> potential, they are only eligible if they and any non-sterile, male sexual partners<br> agree to use highly effective contraceptive therapy<br><br> 4. Female subjects must have a negative serum pregnancy test at screening<br><br>Inclusion Criteria for Subjects with Normal Hepatic Function:<br><br> 1. Good general health as defined by no clinically relevant abnormalities identified by<br> Medical History and a vital signs and 12-lead electrocardiogram (ECG) assessment<br><br> 2. Subjects must fit the demographic-matching criteria including body weight, age, and<br> to the extent possible, gender<br><br> 3. Normal hepatic function with no known or suspected hepatic impairment<br><br>Inclusion Criteria for Subjects with Impaired Hepatic Function:<br><br> 1. Subject satisfies the criteria for Class B of the Child-Pugh classification (Child<br> Pugh Scores 7-9 points) within 28 days of study drug administration<br><br> 2. A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary<br> to any acute ongoing hepatocellular process) documented by medical history, physical<br> examination, liver biopsy, hepatic ultrasound, Fibroscan, computerized tomography<br> scan, or magnetic resonance imaging (MRI)<br><br> 3. Stable hepatic impairment for at least 3 months prior to screening or second<br> screening visit to demonstrate stability<br><br> 4. Stable concomitant medications for the management of an individual subject's medical<br> history for at least 28 days prior to screening<br><br> 5. Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol<br> criteria<br><br>Exclusion Criteria for All Subjects:<br><br> 1. Subjects with any current or previous illness that, in the opinion of the<br> Investigator, might confound the results of the study or pose an additional risk in<br> administering study drug to the subject or that could prevent, limit, or confound<br> the protocol specified assessments or study results' interpretation<br><br> 2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de<br> Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history<br> or clinical evidence at screening of significant or unstable cardiac disease etc.<br><br> 3. Subjects with a history of clinically significant drug allergy<br><br> 4. Subjects with a recent (within 1 year of randomization) history or current evidence<br> of drug abuse or recreational drug use<br><br> 5. Excessive use of alcohol defined as regular consumption of =14 units/ week for women<br> and =21 units/week for men<br><br> 6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study<br> through end of study follow up<br><br> 7. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such<br> as SARS- CoV-2 infection. Subejcts with Hepatitis B infection may be eligible for<br> moderate impairment cohort provided provided they met stable treatment criteria.<br> Subjects with HIV infection may be eligible for moderate impairment cohort provided<br> they met stable treatment criteria.<br><br>Exclusion Criteria for Subjects with Normal Hepatic Function:<br><br> 1. Estimated creatinine clearance <60 mL/min/1.73 m2 at screening, calculated by the<br> Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula] - Unless<br> otherwise instructed by the Study Review Committee (SRC), CKD-EPI should not be<br> corrected for subjects of African ancestry<br><br> 2. Bilirubin (total, direct) >1.2× upper limit of normal (ULN) (unless Gilbert's is<br> suspected)<br><br> 3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 1.2×ULN<br><br> 4. Grade =1 Hemoglobin<br><br>Exclusion Criteria for Subjects with Impaired Hepatic Function:<br><br> 1. Subjects with advanced ascites (Grade 3)<br><br> 2. Subjects with refractory encephalopathy as judged by the investigator.<br><br> 3. Subjects with esophageal variceal bleeding within the past 6 months prior to<br> screening.<br><br> 4. Subjects with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement.<br><br> 5. Estimated creatinine clearance <60 mL/min/1.73 m2 at screening, calculated by the<br> Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula] - Unless<br> otherwise instructed by the SRC, CKD-EPI should not be corrected for subjects of<br> African ancestry<br><br> 6. ALT or AST level =5×ULN<br><br> 7. Serum sodium =125 mmol/L<br><br> 8. Platelets <50×10^9/L<br><br> 9. Grade =2 Hemoglobin
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the concentration time curve [AUC];Time to maximum plasma concentration [Tmax];Maximum plasma concentration [Cmax];Minimum plasma concentration [Cmin];C0 [predose];Half-life [t1/2]
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]