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Study of Alogabat oral 60 mg capsule and IV 100 µg microdose in healthy male participants to assess mass balance, absolute bioavailability and metabolism

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The trial involves a medication called Alogabat. The study is being done in healthy adult men and does not focus on any illness. Participants will receive the drug in two ways: a 60 mg pill taken by mouth (oral) and a very small dose given through a vein (intravenous) using a drip.

The purpose of the study is to learn how the body absorbs, moves, changes, and gets rid of Alogabat, which is measured as its bioavailability (how much of the drug reaches the bloodstream) and its pharmacokinetics (the overall journey of the drug inside the body). After taking the pill, a tiny amount of the drug with a special harmless marker is given by IV, and researchers will collect urine, stool, and sometimes vomit to see where the drug goes, a process called mass balance. The marker allows the team to track the drug without affecting safety.

During the study, participants will stay in a clinical setting for several days while blood, urine, and stool samples are taken at set times to measure the drug’s levels. Vital signs, heart rhythm checks (ECG), and basic lab tests will be done to watch for any side effects. After the sampling period, participants will be released and followed up for a short time to ensure they remain well.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial study visit

    You will attend the study site for the first visit after being accepted into the trial. during this visit, basic health checks such as vital signs, a brief physical exam, an electrocardiogram (ecg), and routine laboratory tests will be performed to confirm eligibility.

    The purpose of these checks is to ensure that you are healthy enough to receive the study medications and to provide reference values for later comparison.

  2. Step 2

    Administration of oral capsule

    You will swallow a single oral capsule containing 60 mg of alogabat. the capsule is a hard, solid form that is taken by mouth with water.

    This dose is given only once during the study and is taken at the start of the dosing day.

  3. Step 3

    Intravenous microdose infusion

    Immediately after taking the capsule, a healthcare professional will place an intravenous (iv) line in a vein and deliver a microdose of alogabat. the infusion contains 100 µg (micrograms) of alogabat in a solution for infusion.

    The infusion is administered over a short period, typically a few minutes, and is also a one‑time event.

  4. Step 4

    Post‑dose monitoring

    Following both the oral capsule and the iv infusion, you will remain at the study site for a monitoring period. during this time, vital signs, ecg readings, and selected laboratory tests will be repeated to observe any immediate effects of the medications.

    Any symptoms or adverse events you experience will be recorded by the study staff.

  5. Step 5

    Collection of urine and feces samples

    Over the days after dosing, you will be asked to provide all urine and feces you produce. these samples are used to determine how much of the drug is eliminated from the body and through which routes.

    Samples may be collected at the clinic or at home and will be stored according to study procedures until they can be analyzed.

  6. Step 6

    Final assessments and study completion

    Once the required urine and feces collections are finished, you will return to the study site for a final set of vital sign checks, ecg, and laboratory tests.

    After these final assessments, the study participation is considered complete.

Who can join the trial?

5 criteria

  • Be able and willing to sign a written informed consent form and follow the study rules.
  • Be between 18 and 55 years old when you sign the consent form.
  • Be a biological male who is healthy, meaning you have no current or long‑lasting illnesses. Health will be checked with a detailed medical history, a full physical exam, measurements of vital signs (like blood pressure and heart rate), a 12‑lead electrocardiogram (ECG) (a test that records the heart’s electrical activity), and blood and urine laboratory tests.
  • Have a body mass index (BMI) from 18.5 to 30 and weigh between 50 kg (about 110 lb) and 110 kg (about 242 lb) at the screening visit. BMI is a calculation that uses your height and weight to see if you are underweight, normal weight, or overweight.
  • Agree to avoid causing a pregnancy for the time you are in the study and for at least 90 days after the last dose. This can be done by not having heterosexual intercourse, using a condom with a partner who could become pregnant, or if the partner is already pregnant. You must also agree not to donate semen during this period.

Who cannot join the trial?

6 criteria

  • Having any medical condition that could change how the body absorbs (takes in), metabolizes (processes), or eliminates (gets rid of) medicines.
  • Having a serious disease affecting the gastrointestinal (stomach/intestines), renal (kidneys), hepatic (liver), bronchopulmonary (lungs/breathing), neurological (brain/nerves), psychiatric (mental health), cardiovascular (heart/blood vessels), endocrinological (hormone glands), hematological (blood), severe allergic disease, a metabolic disorder (problem using energy), hypofertility (reduced ability to have children), cancer, or cirrhosis (severe liver scarring).
  • Having a history of convulsions (seizures) except harmless fever‑related seizures in childhood, including epilepsy, or having had a serious head injury (cerebral trauma) or a brain or spinal‑cord infection (central nervous system infections) such as meningitis (infection of the membranes around the brain).
  • Having taken part in any research or medical test that used PET (a scan that uses a tiny amount of radioactive material) or other radiological investigations (like X‑rays or CT scans) within the past 12 months.
  • Having donated more than 500 mL of blood or blood products (about one pint) or having lost a large amount of blood in the three months before screening.
  • Having been exposed to ionizing radiation (high‑energy radiation such as X‑rays that can affect cells) within the year before receiving the study medication.
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Investigated drugs

  • Alogabat (oral capsule)

    is a pill taken by mouth that contains the study drug Alogabat. In this trial participants swallow the capsule to see how well the medicine is absorbed into the body when taken by mouth. The researchers will measure how much of the drug reaches the bloodstream and how the body processes it. This helps determine the drug’s bioavailability, which is how much of the medicine becomes available to work after oral dosing.

  • Alogabat (intravenous solution)

    is a liquid form of the same study drug that is given directly into a vein through a short infusion. A very small amount (a microdose) is administered so it can serve as a reference point for comparing the oral capsule. By delivering the drug straight into the bloodstream, the study can see how the body handles Alogabat without the effects of digestion, providing a clear picture of its absolute bioavailability.

What is already known about the treatment

Alogabat - Alogabat can be given as a hard capsule taken by mouth or as a sterile solution for intravenous infusion. It is still an investigational drug and has not been approved for any clinical use, with only early‑phase studies in healthy volunteers reported in the literature. The drug is being explored for possible use in disorders of the nervous system and psychiatric conditions, although no specific indication is approved yet. Alogabat works by binding to GABA receptors in the brain, which helps increase the calming signal of the nervous system, and it is classified as a central nervous system‑active GABA‑modulating agent.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506044-16-00Protocol codeBP41817Estimated enrolment8 patientsSponsorF. Hoffmann-La Roche AG

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