NCT06480968

Who might be able to join this trial:

• You are a healthy male, or a healthy female who cannot become pregnant (either due to surgical sterilisation such as a hysterectomy or tubal ligation, or because you have gone through menopause).
• You are between 18 and 55 years old.
• You weigh between 50 kg and 100 kg.
• Your Body Mass Index (BMI) is between 18 and 30 (a measure of body weight relative to height).
• You have a negative pregnancy test (women only).
• You are a non-smoker.
• You have no history of, and are not currently experiencing, any significant health conditions or illnesses.
• Your physical check-up, blood pressure, heart rate, body temperature, heart tracing (ECG), and blood/urine tests all come back normal or are considered acceptable by the doctor.
• You are willing and able to follow restrictions on food, exercise, alcohol, and caffeine-containing products throughout the trial.
• You can read Spanish or Catalan and are able to follow the study requirements.
• You are not under any legal or administrative supervision.
• You are willing to sign a consent form before any study procedures begin.
• If you are male, you are willing to use double barrier contraception (condom and spermicide), avoid donating sperm, and avoid trying to conceive for the duration of the study and for 90 days after it ends.

Who may not be able to join:

• Women who are able to become pregnant.
• Anyone with a lifetime history of substance use disorder (problems with drug or alcohol dependency).
• Anyone who has used recreational drugs in the month before the study drug is given (this will be checked using a hair test).
• Anyone who tests positive for drugs of abuse or alcohol at the time of the study.
• Anyone with a lifetime history of mental health conditions.
• Anyone who has experienced anxiety or depression that has not fully resolved within the 12 months before the study, as assessed through a screening interview.
• Anyone with significant memory or thinking difficulties that would prevent completion of the study's psychological tests.
• Anyone with a health condition or circumstance that, in the doctor's opinion, could affect their ability to take part safely or affect the study results.
• Anyone with current or past stomach or bowel conditions, or bowel surgery that could affect how the body absorbs medication.
• Anyone who has had a significant illness in the month before the study drug is given.
• Anyone with abnormal results in their physical check-up, vital signs, ECG, or blood/urine tests.
• Anyone with a notably prolonged measurement on their heart tracing (ECG) called the QT/QTc interval (repeatedly above 450 ms).
• Anyone with additional risk factors for a serious heart rhythm problem called Torsades de Pointes (TdP), such as heart failure, low potassium levels, or a family history of Long QT Syndrome.
• Anyone currently taking medications known to affect heart rhythm (QT/QTc interval).
• Anyone who tests positive for hepatitis or HIV.
• Anyone with a known allergy or sensitivity to the study drug or any of its ingredients.
• Anyone who has used medications known to affect how the liver processes drugs in the month before the study, or who consumes citrus juice (such as grapefruit juice) during the study.
• Anyone who has taken any prescription or over-the-counter medicines, herbal products, vitamins, minerals, or nutritional supplements within 2 weeks before the study drug is given (or longer, depending on the product).
• Anyone who has donated blood or plasma in the month before the study, has received a blood transfusion, or plans to donate blood or plasma within one month after the study ends.
• Anyone with a history of poor vein access or difficulty having blood taken.
• Anyone unwilling or unable to follow the dietary, exercise, alcohol, and caffeine restrictions required during the study.
• Anyone who has taken part in another clinical trial within 3 months before the study drug is given.
• Anyone already participating in another part of this same study.

Important: Always verify eligibility with the trial site directly before applying.