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A study of the effects of AGMB-129 and midazolam in healthy participants

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What is this study about?

This study examines how a new substance called ORG-129 affects the body’s processing of midazolam, a medication used to produce sedation. The research focuses on how these two substances interact when taken together. While Fibrostenotic Crohn’s disease, a type of Crohn’s disease characterized by scarring and narrowing of the intestines, is mentioned in the medical context, this specific study is being conducted in healthy individuals to observe the pharmacokinetics, which refers to how a drug moves through, is distributed in, and is eliminated from the body.

The purpose of the study is to determine the effect of ORG-129 on the levels of midazolam and its metabolite, which is a substance created when the body breaks down a drug. During the study, participants will receive the medications in a specific sequence. Monitoring will include checking vital signs, such as blood pressure and heart rate, as well as conducting physical exams and laboratory tests to ensure safety and observe the effects of the substances on the body.

Who Can Join the Study?

  • You must voluntarily sign an Informed Consent Form, which is a document you sign to show that you understand the study and agree to take part.
  • You must be willing to follow the lifestyle rules described in the study plan.
  • You must be a male or female between the ages of 18 and 55.
  • Your weight must be at least 50.0 kg for men and 45.0 kg for women.
  • Your Body Mass Index (BMI), which is a measure of your weight relative to your height, must be between 19.0 and 30.0.
  • Men must either have had a vasectomy (a permanent procedure to prevent pregnancy) or agree to use specific protection or avoid certain activities to prevent pregnancy during and for 4 weeks after the study.
  • Women must not be pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
  • Women must use a highly effective contraceptive method (a way to prevent pregnancy that works almost 100% of the time) or agree to abstain from sex, and must not donate eggs during the study.
  • Women must have a negative serum beta human chorionic gonadotropin (β-hCG) test, which is a highly sensitive blood test used to check for pregnancy, and a negative urine pregnancy test.
  • You must be in good health as determined by a doctor looking at your medical history, a physical exam, your vital signs (such as blood pressure and heart rate), and a 12-lead ECG (a test that records the electrical activity of your heart).
  • Your liver function tests, including total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT), must be within a specific healthy range.
  • Other laboratory safety tests must show results that are within the normal range.
  • You must test negative for alcohol and certain drugs of abuse, such as amphetamines, cocaine, and opiates, through a urine and breath test.
  • You must have a negative COVID-19 PCR test (a highly accurate test that looks for the virus’s genetic material) and show no symptoms of the virus.

Who Cannot Join the Study?

  • You have a known hypersensitivity, which means a known allergy, to any of the ingredients in the study drug.
  • You have taken any medicine in the last 3 months that is known to potentially cause organ toxicity, or serious damage to organs like the liver or kidneys.
  • You have used any medications, vitamins, herbal supplements, or dietary supplements in the last 14 days, except for occasional paracetamol (a common pain reliever) within specific dose limits, or certain hormonal medications.
  • You have received or plan to receive a live vaccine (a type of vaccine that uses a weakened form of a germ) within the last 4 weeks, though emergency vaccines like COVID-19 are allowed.
  • You have participated in another study involving drugs or medical devices within the last 30 days, or a study involving biologics (medicines made from living organisms) within the last 3 months.
  • You have a history of drug or alcohol abuse within the last 2 years, where alcohol abuse is defined as drinking more than 14 units per week.
  • You are a current smoker or have used e-cigarettes, nicotine, or nicotine products within the last 6 months.
  • You regularly consume large amounts of xanthine-containing products, such as more than 6 cups of coffee or tea per day, chocolate, cola, or energy drinks.
  • You are a relative of, or are directly involved in, the staff conducting this study.
  • You have any medical condition that the doctor believes might prevent you from safely completing the study or following the rules.
  • You have poor venous access, which means it is difficult for medical staff to find a vein to take blood samples.
  • You test positive for hepatitis B or hepatitis C, or have a history of any type of hepatitis except for hepatitis A that was cured at least 3 months ago.
  • You have any condition that makes the use of midazolam (a sedative medicine) unsafe, such as breathing problems or acute narrow-angle glaucoma (a sudden increase in eye pressure).
  • You have a condition that weakens your immune system (the body’s defense against germs), including having HIV.
  • You have or have had vasculitis (inflammation of the blood vessels), heart valve disease, or vascular disease (problems with large blood vessels, such as an aneurysm).
  • You have had any illness in the last 3 months that the doctor considers significant.
  • You have any issues with your stomach, liver, or kidneys, specifically if your eGFR (a measurement of how well your kidneys filter blood) is 80 mL/min or lower.
  • You have had malignancy (cancer) within the last 5 years, except for certain types of skin cancer that were fully removed and cured.
  • You have abnormal results on an ECG (a test that records the electrical activity of your heart), specifically issues with heart rhythm or QT interval (the time it takes for your heart muscle to recharge between beats).
  • You have had a large amount of blood loss, such as donating more than 450 mL of blood, or received a blood transfusion within the last 3 months.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
SGS Belgium Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
21.06.2023

Trial locations

Investigated drugs:

ORG-129 is the experimental drug being tested in this study to see how it affects the body and how it interacts with other medicines.

Midazolam is a medication used in this study as a standard tool to measure how the experimental drug changes the way the body processes certain substances.

Investigated diseases:

Fibrostenotic Crohn’s disease – This is a type of Crohn’s disease characterized by the development of thick, scarred tissue within the digestive tract. It involves chronic inflammation that leads to the formation of strictures, which are narrowings in the intestinal walls. As the disease progresses, these narrow areas can cause obstructions that hinder the normal passage of food and waste. The buildup of fibrous tissue gradually makes the intestinal passages tighter over time.

Trial ID:
2023-504461-23-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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