A Single-dose Open-label Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    40
  • sponsor
    Galectin Therapeutics Inc.
Updated on 15 September 2021
ct scan
electrocardiogram
body mass index
direct bilirubin
liver disease
prothrombin
12 lead ECG
medication regimen
drug tests
hepatic ultrasound

Summary

This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched healthy control subjects.

Details
Condition Hepatic Impairment
Treatment belapectin
Clinical Study IdentifierNCT04332432
SponsorGalectin Therapeutics Inc.
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All Subjects
Males or females, of any race, between 18 and 75 years of age, inclusive
Body mass index between 18.0 and 45.0 kg/m2, inclusive
Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at Screening and Check-in. Females of childbearing potential must agree to use contraception by a method of proven reliability (including abstinence) for the duration of the study
Males will agree to use contraception
Male subjects must not donate sperm from Check-in (Day -1) until 90 days after the Follow-up visit
Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions
Subjects with Normal Hepatic Function Only
\. In good health, determined by no clinically significant findings from
medical history, physical examination, 12 lead electrocardiogram (ECG), vital
signs measurements, and clinical laboratory evaluations (congenital
nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on
total and direct bilirubin] is not acceptable) at Screening and Check in (Day
), as assessed by the Investigator (or designee)
\. Matched to subjects with mild, moderate, or severe hepatic impairment in
sex, age (10 years), and body mass index (BMI) (20%)
Subjects with Hepatic Impairment Only
\. Documented chronic stable liver disease based on Child-Pugh score and
classification (Child-Pugh Class A [mild], B [moderate], or C [severe]; at
Screening and Check-in (if the classification differs when assessed at Check-
in compared to Screening, enrollment of the subject into a hepatic category
will be based on the score at Screening)
'Documented' is defined by at least 1 of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy
'Chronic' is defined as >6 months
'Stable' is defined as no clinically significant change in disease status within the last 1 month (30 days), as documented by the subject's recent medical history (eg, no worsening of clinical signs of hepatic impairment, or no worsening of total bilirubin or prothrombin time, at the discretion of the Investigator [or designee] or Medical Monitor). 10. Subjects with mild, moderate, or severe hepatic impairment may have medical findings consistent with their hepatic dysfunction as determined by medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in (Day -1), as assessed by the Investigator (or designee). 11. Non-hepatic, abnormal clinical laboratory evaluations must not be clinically relevant, as judged by the Investigator (or designee) and Medical Monitor. 12. Currently on a stable medication regimen, defined as not starting new drug(s) or changing drug dose(s) within 30 days of administration of study drug (Day 1). Concomitant medications administered within 30 days prior to administration of study drug (Day 1) must be approved by the Investigator (or designee), Sponsor, and Medical Monitor. 13. Anemia secondary to hepatic disease will be acceptable, if hemoglobin is > 9 g/dL and anemia symptoms are not clinically significant as judged by the Investigator (or designee) and Medical Monitor. 14. Subjects must have a platelet count 35 10^9 platelets/L

Exclusion Criteria

All Subjects
Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)
Alcohol consumption of > 21 drinks per week for males and > 14 drinks for females
Positive urine drug screen at Screening and/or Check in (Day -1), that is not otherwise explained by permitted concomitant medication or ingestion of poppy seeds, or positive alcohol test result (breath or urine in accordance with standard practice at each CRU) at Screening or Check-in (Day -1)
Positive human immunodeficiency virus test
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days, or 5 half-lives (whichever is longer), prior to dosing
Ingestion of Seville orange or grapefruit containing foods or beverages within 7 days prior to Check-in (Day -1)
Receipt of blood products within 2 months prior to Check in (Day -1)
Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening
Poor peripheral venous access
Have previously completed or withdrawn from this study or any other study investigating belapectin, and have previously received belapectin
Subjects who, in the opinion of the Investigator (or designee), should not participate in this study
Subjects with Normal Hepatic Function Only
\. History of alcoholism or drug/chemical abuse within 2 years prior to
Check in
\. Subject has creatinine clearance <90 mL/minute as calculated by using the
Cockcroft Gault equation
[1.23 (140 - age) (weight in kg)] (serum creatinine in mol/L) - if male
[1.04 (140 - age) (weight in kg)] (serum creatinine in mol/L) - if female
Confirmed supine blood pressure > 140 mmHg or < 90 mmHg and/or supine diastolic blood pressure > 90 mmHg or < 50 mmHg, or resting (supine) heart rate < 45 bpm or > 100 bpm at Screening or Check-in (Day -1), with a QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 ms for male subjects and > 470 ms for female subjects
Use or intend to use any prescription medications/products other than prescribed hormone replacement therapy or contraception within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee)
Use or intend to use slow release medications/products considered to still be active within 14 days prior to Check in (Day -1), unless deemed acceptable by the Investigator (or designee)
Use or intend to use any nonprescription medications/products including vitamins and minerals within 7 days prior to Check in (Day -1), unless deemed acceptable by the Investigator (or designee)
Positive serology test results for hepatitis A, hepatitis B antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies
Clinically significant abnormal laboratory values (clinical chemistry, hematology, coagulation, and urinalysis), as determined by the Investigator (or designee)
Significant history or clinical manifestation of hepatic disorder, as determined by the Investigator (or designee)
History or presence of liver disease or liver injury as indicated by any clinically significant deviations from normal reference ranges in liver function tests, unless approved by the Investigator (or designee)
Use of tobacco- or nicotine-containing products within 3 months prior to Check in (Day -1), or positive cotinine test at Screening or Check-in
Subjects with Hepatic Impairment Only
\. Cirrhosis etiology of primary biliary cholangitis or primary sclerosing
cholangitis
\. History of alcoholism or drug/chemical abuse within 6 months prior to
Check in
\. Evidence of hepatorenal syndrome and/or creatinine clearance < 45 mL/min
as calculated using the Cockcroft-Gault equation
[1.23 (140 - age) (weight in kg)] (serum creatinine in mol/L) - if male
[1.04 (140 - age) (weight in kg)] (serum creatinine in mol/L) - if female
Confirmed supine blood pressure > 150 mmHg or < 90 mmHg and/or supine diastolic blood pressure > 90 mmHg or < 50 mmHg, or resting (supine) heart rate < 45 bpm or > 100 bpm at Screening or Check-in (Day -1), with a QTcF > 480 ms for male and female subjects
Use or intend to use any prescription medications/products within 14 days of study drug administration, with the exception of
stable medication regimen, as approved by the Investigator (or designee), Sponsor, and Medical Monitor; see inclusion criterion 12
prescribed hormone replacement therapy
prescribed contraceptive
Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee)
Positive serology test results for hepatitis A, hepatitis B DNA (hepatitis B DNA levels will be analyzed if subject tests positive for HBsAg or hepatitis B core antibodies), or hepatitis C RNA (hepatitis C RNA levels will be analyzed if subject tests positive for hepatitis C antibodies)
Clinically significant abnormal physical examination, vital signs, and/or ECG findings that are not consistent with their degree of hepatic dysfunction, as determined by the Investigator (or designee)
Recent history, or the treatment of, esophageal bleeding (within the 180 days prior to Screening), unless banded
History of hepatic shunt surgery or presence of a portosystemic shunt
History of paracentesis within 7 days prior to screening. Paracentesis will not be permitted throughout the study
Current functioning organ transplant or likely to be transplanted within the next two months
Evidence of severe ascites needing paracentesis/not controlled by medication
Current symptoms or recent history of hepatic encephalopathy (Grade 2 or above) at Screening
Smoke more than 10 cigarettes, or use the equivalent tobacco or nicotine containing products (including vaping), per day or inability to refrain from tobacco/nicotine use 2 hours predose until 4 hours postdose
Unstable diabetes as evidenced by hemoglobin A1c > 9%
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note