Not recruitingRare disease

A study to evaluate how the body processes AZ-3102 in healthy male subjects

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 focuses on Glycosphingolipid lysosomal storage disorders, which are a group of rare genetic conditions where the body cannot properly break down certain types of fats. The investigation involves a test substance known as AZ-3102. The purpose of the study is to understand how the body processes and eliminates this medication.

Participants will receive a single oral dose of the AZ-3102 capsule. Following the administration, researchers will monitor how the substance is absorbed into the body, how it is changed by biological processes, and how it is eventually removed through bodily waste. This includes examining the plasma, which is the liquid part of the blood, as well as urine and feces. This process helps determine the pharmacokinetics, or the way the body handles the drug over time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>single dose administration</b>
A single 9 mg capsule of the test substance, known as AZ-3102, is taken by mouth.
The substance is administered as a single oral dose.
Step 2
<b>monitoring and collection</b>
The processes of absorption (how the drug enters the blood), metabolism (how the body breaks down the drug), and excretion (how the body removes the drug) are monitored.
Samples of urine and feces (waste matter) are collected to measure the total amount of radioactivity released by the body.
Samples of plasma (the liquid part of blood) are collected to study the metabolic profile of the substance.
Safety monitoring is performed, which includes checking vital signs (such as heart rate and blood pressure), conducting ECG (a test that records the electrical activity of the heart), and performing laboratory tests to identify any side effects or abnormal findings.

Who can join the trial?

14 criteria

You must be able and willing to sign a written informed consent, which is a document where you agree to take part in the study after being told all the details.
You must be able to follow all the rules and requirements of the study.
You must have a negative urine drug screen, meaning a urine test shows no illegal drugs or other prohibited substances in your system.
You must be able to communicate clearly with the medical team to ensure you understand the study instructions.
You must be a healthy male between the ages of 18 and 65 years old.
If you have a female partner who could become pregnant, you must agree to use contraception (methods to prevent pregnancy) during the study and for up to 14 weeks after leaving the clinic.
You must agree not to donate sperm during the study and for up to 14 weeks after leaving the clinic.
Your physical examination, which is a general check of your body by a doctor, must show no significant health problems.
Your Body Mass Index (BMI), which is a measure of your body weight relative to your height, must be between 18.0 and 30.5.
Your systolic blood pressure (the top number in a blood pressure reading) must be between 90 and 140 mmHg.
Your diastolic blood pressure (the bottom number in a blood pressure reading) must be between 45 and 90 mmHg.
Your pulse rate (the number of times your heart beats per minute) must be between 40 and 100 beats per minute.
Your electrocardiogram (ECG), which is a test that records the electrical activity of your heart, must show no abnormal results.
Your hematology (blood cell counts), coagulation (how well your blood clots), clinical chemistry (tests checking chemicals like sugar or salt in your blood), and urinalysis (testing your urine) must all show results within the normal range.

Who cannot join the trial?

22 criteria

You cannot participate if you have taken part in another study that involved radiation exposure (exposure to energy that can travel through the body, like X-rays) within the last 1 to 3 years, depending on the amount of radiation received.
You cannot participate if you have a history of chronic dermatological conditions, which are long-term skin problems that required regular medical care.
You cannot participate if you have a history of corneal erosions (scratches on the clear front part of the eye), degenerations (wearing away of eye tissue), or keratitis (inflammation of the cornea).
You cannot participate if the veins (the tubes that carry blood) in either arm are too difficult to find, access, or use for intravenous puncture (inserting a needle into a vein to give medicine or take blood).
You cannot participate if you have previously taken the study medication being tested.
You cannot participate if you have used an investigational treatment (a medicine that is still being studied) within the last 3 months, or if you have participated in more than four such studies in the past year.
You cannot participate if there is a history or evidence of alcoholism or drug abuse within the last 2 years.
You cannot participate if you consume excessive caffeine, defined as 800 mg or more per day.
You cannot participate if you have smoked within the last 3 months or are unable to stop smoking during the study.
You cannot participate if you have taken prescribed medications (including vaccines), over-the-counter medications (medicines you buy without a prescription, such as vitamins or herbal supplements), or homeopathic preparations within specific timeframes before the study, except for paracetamol.
You cannot participate if you had a significant blood loss in the last 3 months, or if you lost plasma (the liquid part of blood) in the last 7 days, or platelets (cells that help blood clot) in the last 42 days.
You cannot participate if you had exposure to radiation (other than standard dental or chest X-rays) within the last year.
You cannot participate if you test positive for hepatitis (an infection that affects the liver), unless you have been vaccinated or have already recovered from it.
You cannot participate if you test positive for HIV (a virus that attacks the body's immune system).
You cannot participate if the investigator (the main doctor in charge of the study) believes any of your conditions might prevent you from following the study rules or could make the results unclear.
You cannot participate if you have legal incapacity (a legal status where you cannot make certain decisions for yourself).
You cannot participate if you have a known hypersensitivity (an allergic reaction) to the study medication or similar types of drugs called iminosugars or azasugars.
You cannot participate if you have any medical or surgical condition that might change how the body absorbs, distributes, metabolizes, or excretes (how the body takes in, moves, breaks down, or gets rid of) the medicine; for example, having your gallbladder removed is not allowed.
You cannot participate if your estimated creatinine clearance (a measurement of how well your kidneys are filtering waste from your blood) is less than 90 mL/min.
You cannot participate if you have infrequent bowel movements (pooping less than once every two days) or a recent history of diarrhea or loose stools.
You cannot participate if you have a history of fainting, syncope (sudden loss of consciousness), orthostatic hypotension (a sudden drop in blood pressure when standing up), or vasovagal reactions (fainting due to a trigger like stress or pain) in the past year.
You cannot participate if you have a history of seizures (sudden, uncontrolled electrical disturbances in the brain).

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Verified sites

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Pharmaceutical Research Associates Group B.V.
Verified
Groningen, The Netherlands

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Investigated drugs

AZ-3102 is an experimental medication being studied to see how the body absorbs, processes, and gets rid of it after being taken by mouth.

(2S,3R,4R,5S)-1-[5-(2-FLUORO-BIPHENYL-4-YLMETHOXY)-PENTYL]-2-HYDROXYMETHYL-PIPERIDINE-3,4,5-TRIOL

What is already known about the treatment

AZ-3102 - This medication is an experimental drug taken by mouth in capsule form that is currently being studied in early-stage clinical trials. It is being developed to treat rare metabolic conditions known as glycosphingolipid lysosomal storage disorders by helping the body properly manage certain fats. At a molecular level, it works by targeting specific enzymes to correct the buildup of substances that cause cellular damage. It is classified as an investigational orphan drug intended for specialized metabolic therapy.

Investigated diseases

Glycosphingolipid lysosomal storage disorders - These are a group of rare genetic conditions where the body cannot properly break down specific types of fats called glycosphingolipids. Because an enzyme is missing or not working correctly, these fats build up inside the lysosomes, which are the cleaning compartments of the cells. As these substances accumulate, they interfere with the normal functioning of various cells throughout the body. The progression typically involves the gradual buildup of these materials in different organs and tissues. This accumulation can affect various systems, including the nervous system and other vital organs.