Study of Aticaprant Oral Tablet vs Small IV Dose to Measure How Well It Is Absorbed in Healthy Adults
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study involves healthy adult volunteers who do not have any known medical condition. Participants will receive a single dose of the experimental drug aticaprant in two forms: a standard oral tablet taken by mouth and a very small amount given by an intravenous infusion. The oral tablet contains 10 mg of the medication, while the infusion provides a microdose of 100 µg of a radiolabeled version of the same drug.
The purpose of the study is to determine the drug’s bioavailability, meaning how much of the medication reaches the bloodstream when taken as a pill compared with the tiny IV dose. By comparing the two administrations, researchers can learn how the body absorbs and processes the medication.
Volunteers will first swallow the tablet, then, after a short waiting period, receive the IV microdose. Blood samples will be collected at several time points over the next few hours to measure the amount of drug in the blood. The entire procedure is completed within a single visit, and no additional treatments are given.
The research process
The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
14 criteria
- Be a healthy adult, male or female, aged between 18 and 55 years.
- Have a normal medical history, physical exam, vital signs and a 12‑lead ECG (heart test) that shows:
- regular sinus rhythm (normal heartbeat pattern),
- heart rate between 40 and 100 beats per minute,
- QTcF interval (a measurement of heart electrical recovery) ≤ 450 ms for men and ≤ 470 ms for women,
- QRS interval (time for heart’s electrical signal to travel) less than 120 ms,
- PR interval (time from start of atrial to ventricular contraction) less than 210 ms,
- overall appearance consistent with healthy heart function.
- Show normal results on laboratory tests (blood and urine), and have liver enzymes (ALT, AST, ALP) and bilirubin no more than 1.5 times the upper normal limit.
- Weigh at least 50 kg and have a body‑mass index (BMI) between 18.0 and 29.9 kg/m².
- If you are a woman who could become pregnant, you must have a negative blood test for β‑human chorionic gonadotropin (β‑hCG) and a negative urine pregnancy test before starting the study.
- Women who could become pregnant must use a highly effective method of contraception (failure rate less than 1 % per year) and continue using it until 30 days after the last dose.
- Women must agree not to donate, freeze, or store eggs for assisted reproduction during the study and for at least 3 months after the last dose.
- Men must agree to use a barrier method of contraception (such as a condom with spermicide) during the study and for about 3 months after the last dose, and must not donate sperm during that time.
- Blood pressure measured after lying down for 5 minutes must be between 90 and 140 mm Hg systolic and no higher than 90 mm Hg diastolic at screening and on the day of dosing.
Who cannot join the trial?
17 criteria
- Any serious health problem such as irregular heartbeat (cardiac arrhythmias), heart disease, blood disorders (hematologic disease), problems with blood clotting (coagulation disorders), abnormal cholesterol (lipid abnormalities), lung disease (pulmonary disease), asthma‑like breathing problems (bronchospastic disease), diabetes, liver or kidney failure (kidney function measured by creatinine clearance below 60 mL/min), thyroid problems, brain or mental illness (including Parkinson’s disease), infections, high blood pressure (hypertension), blood‑vessel disease, or any other illness that could affect the study results.
- Having had cancer within the past 5 years, except for certain skin cancers (squamous or basal cell) and early cervical cancer that are considered cured.
- Known allergy or sensitivity to the study drug aticaprant or any of its inactive ingredients (excipients).
- Abnormal heart test results (a 12‑lead ECG), abnormal vital signs (such as blood pressure or heart rate), or abnormal findings on a physical exam that the doctor thinks are important.
- Recent stomach ulcer (within 6 months), any serious stomach bleeding in the past, untreated Helicobacter pylori infection, a rare condition that makes too much stomach acid (Zollinger‑Ellison syndrome), or stomach/intestine surgery that could change how the drug is absorbed.
- Major surgery that required general anesthesia within the last 12 weeks, not fully recovered from such surgery, or planned surgery during the time you would be in the study.
- Current thoughts of harming yourself or others, or recent suicide thoughts or attempts (within the past 3‑6 months).
- Any medical reason that makes taking aticaprant unsafe, as listed in the drug’s prescribing information.
- Use of medicines, vitamins, herbal products, or mineral supplements (except limited use of acetaminophen/paracetamol) within 14 days before the first dose.
- Taking any prohibited medicines or therapies listed in the study’s protocol before the first dose.
- Having received any experimental drug, vaccine, or invasive medical device within the past month (or longer if the drug’s half‑life requires it) or being enrolled in another clinical study.
- Testing positive for illegal drugs or alcohol on the pre‑study screening.
- Positive test for HIV (human immunodeficiency virus) antibodies.
- Positive test for active hepatitis B infection (presence of hepatitis B surface antigen or core antibody).
- Positive test for hepatitis C antibodies (indicating exposure) without a confirmatory negative hepatitis C RNA test to show the virus is not active.
- Positive test for active hepatitis C infection (presence of hepatitis C RNA).
- Positive test for active hepatitis A infection (presence of hepatitis A IgM antibody).
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Investigated drugs
Aticaprant
is being tested as an oral tablet. In the study participants swallow a single tablet, which allows researchers to see how much of the medicine is absorbed into the bloodstream when taken by mouth. This helps determine the drug’s overall availability and how quickly it works after oral dosing.
Aticaprant
is also being tested as an intravenous (IV) infusion solution. A very small amount of the drug, labeled with a harmless radioactive marker, is injected directly into a vein. This method lets scientists measure how the drug behaves when it enters the blood immediately, providing a clear picture of its absorption and distribution without the influence of digestion.
What is already known about the treatment
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?