Not recruiting

Study comparing how the body processes GB1211 capsule and tablet forms with and without food in healthy volunteers

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at GB1211, a medicine that works as a galectin-3 inhibitor, which is being developed for treating Non-small Cell Lung Cancer and Advanced liver Fibrosis and Cirrhosis. Non-small Cell Lung Cancer is a type of lung cancer, while Advanced liver Fibrosis and Cirrhosis refers to scarring and damage of the liver that has progressed to a severe stage. The medicine will be given in two different forms: as a hard capsule and as a tablet. The study will compare how the body processes the medicine when given as a capsule versus a tablet, and will also look at whether eating food affects how the body handles the tablet form of the medicine.

The purpose of the study is to compare how the medicine moves through the body when taken as a capsule without food and when taken as a tablet both with and without food. The study will also assess whether the medicine is safe and well-tolerated in healthy volunteers. This is a crossover study, which means that each person will receive the medicine in different forms and under different conditions during separate treatment periods.

During the study, participants will receive the medicine by mouth in three different ways across three separate periods. Blood and urine samples will be collected to measure the amount of medicine in the body over time. Safety will be monitored throughout the study by checking physical health, body weight, any side effects that occur, laboratory test results from blood and urine samples, blood pressure and heart rate measurements, and heart activity using an electrocardiogram, which is a test that records the electrical signals of the heart.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Informed consent and screening
Before any procedures begin, you will be required to provide written informed consent.
During the screening phase, your physical health will be assessed through several tests including blood tests (to check blood cells and chemistry), urine tests, physical examination, measurement of vital signs (such as blood pressure and heart rate), and an electrocardiogram (a test that records the electrical activity of your heart).
Step 2
First treatment period
You will receive a single dose of GB1211 in capsule form.
This medication will be taken by mouth while you are fasting (without having eaten).
Blood samples will be collected at specific times after taking the medication to measure how the drug moves through your body.
Urine samples will also be collected to assess how much of the drug is eliminated from your body.
Step 3
Washout period after first treatment
A break period will occur between treatment periods to allow the medication to be completely cleared from your body before the next dose.
Step 4
Second treatment period
You will receive a single dose of GB1211 in tablet form.
This medication will be taken by mouth while you are fasting (without having eaten).
Blood samples will be collected at specific times after taking the medication to measure how the drug moves through your body.
Urine samples will also be collected to assess how much of the drug is eliminated from your body.
Step 5
Washout period after second treatment
Another break period will occur to allow the medication to be completely cleared from your body before the next dose.
Step 6
Third treatment period
You will receive a single dose of GB1211 in tablet form.
This medication will be taken by mouth after you have eaten a meal (in a fed condition).
Blood samples will be collected at specific times after taking the medication to measure how the drug moves through your body.
Urine samples will also be collected to assess how much of the drug is eliminated from your body.
Step 7
Safety monitoring throughout all periods
Throughout the study, your safety will be monitored through physical examinations, weight measurements, blood tests, urine tests, vital signs measurements, and electrocardiograms.
Any side effects or health changes you experience will be recorded and assessed.
Step 8
End of study
After completing all three treatment periods and the required assessments, your participation in the study will be complete.

Who can join the trial?

6 criteria

You must provide written informed consent, which means you must sign a document showing you understand and agree to join the study before any screening tests are done
You must be between 18 and 55 years old on the day you sign the consent form
You must be male or female
You must be in good physical health as determined by the study doctor, which will be checked through your medical history, blood tests, urine tests, physical examination, measurement of your heart rate and blood pressure, and a test called an ECG which records the electrical activity of your heart
If you are a woman who can become pregnant, you must agree not to try to become pregnant and not to donate eggs during the study and for 180 days after receiving the last dose of the study medicine
If you are a woman who can become pregnant, you must agree to use a highly effective method of birth control during the study and for 180 days after the last dose, which can include birth control pills containing hormones, vaginal rings, skin patches, hormone injections, hormone implants under the skin, an IUD which is a device placed in the uterus to prevent pregnancy, a hormone-releasing system placed in the uterus, having both fallopian tubes blocked, having a partner who has had a vasectomy which is a procedure to prevent sperm release, or complete avoidance of sexual intercourse

Who cannot join the trial?

3 criteria

The study document does not list specific exclusion criteria, which are reasons why someone cannot participate in the research study
If you are interested in this study, you will need to discuss with the study team to learn about any health conditions, medications, or other factors that might prevent participation
Generally, clinical trials have rules about who can join to ensure the safety of participants and the accuracy of the study results

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Verified sites

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Verified
UMCG
Groningen, The Netherlands

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Investigated drugs

GB1211 is an investigational medication being studied in this trial. It is being tested in two different forms: as a capsule and as a tablet. The study is looking at how the body processes this medication when taken in these different forms, both when participants have not eaten (fasting) and after they have eaten a meal (fed condition). This medication is still being developed and tested, so its specific use or purpose for treating medical conditions is being evaluated.

What is already known about the treatment

GB1211 – GB1211 is an investigational medication currently being studied in clinical trials for the treatment of non-small cell lung cancer and advanced liver fibrosis and cirrhosis. This drug is being tested in both capsule and tablet forms, which are taken by mouth, and researchers are examining how the body processes the medication when taken with or without food. The study aims to understand how different formulations and eating conditions affect the way the drug is absorbed and distributed in the body, which will help determine the best way for patients to take this medication in the future.

Investigated diseases

Non-small Cell Lung Cancer
This is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. It develops when cells in the lungs begin to grow abnormally and form tumors. The disease typically progresses more slowly than small cell lung cancer. As the cancer grows, it can spread to nearby tissues and lymph nodes. In later stages, it may spread to other parts of the body such as the bones, liver, or brain. Common symptoms include persistent cough, chest pain, shortness of breath, and coughing up blood.
Advanced Liver Fibrosis and Cirrhosis
This condition involves progressive scarring of the liver tissue that develops over time due to chronic liver damage. Fibrosis occurs when the liver attempts to repair itself after repeated injury, resulting in the buildup of scar tissue. As fibrosis advances, it can progress to cirrhosis, where extensive scarring disrupts the normal structure and function of the liver. The liver gradually loses its ability to perform essential functions such as filtering toxins from the blood and producing important proteins. This progression can lead to complications including fluid accumulation in the abdomen, bleeding problems, and confusion due to toxin buildup. Common causes include chronic viral hepatitis, excessive alcohol consumption, and fatty liver disease.