NCT03597971

Who might be able to join this trial:

• You must be willing and able to sign a written consent form before joining the study
• You must be a healthy male between 18 and 45 years old at the time of screening
• Your body mass index (BMI) must be between 19.0 and 30.0
• You must have no significant health problems with your liver, bile, or digestive system, based on your medical history and a physical check-up
• Your blood and urine test results must show no significant abnormalities, as decided by the study doctor
• Your heart trace (ECG), blood pressure, and heart rate must show no significant abnormalities, as decided by the study doctor
• You must be willing to use a condom or avoid sexual intercourse throughout the trial and for 3 months after, and must not donate sperm during this time

Who may not be able to join:

• You have a family history of early-onset heart disease
• You have a history of a weakened immune system, serious infections, or have received a live vaccine in the 3 months before screening
• You have active tuberculosis (TB), a history of TB that was not fully treated, or latent (inactive) TB that has not been successfully treated
• You have a history of high blood pressure that needed treatment
• You regularly take any medication for any ongoing health condition
• You have taken any prescription medication in the 30 days before the study starts
• You have taken any other medication — including over-the-counter medicines, herbal remedies, or vitamins — in the 14 days before your first dose (paracetamol/acetaminophen may be an exception)
• You have taken part in another clinical trial using an experimental drug in the 30 days before the study starts, or you are still within an exclusion period from a previous trial
• You have been treated in the past 3 months with any drug known to be potentially harmful to a major organ
• You currently smoke more than 10 cigarettes (or equivalent) per day and are unable to stop completely during the study
• You have had a significant illness in the 3 months before the study
• You have or have had stomach, liver, or kidney disease, or any condition that could affect how your body absorbs or processes drugs
• You have ongoing constipation or diarrhoea, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), haemorrhoids, or any anal condition involving blood in your stools
• You have a history of significant allergies (such as allergies to medications), have had hay fever symptoms in the past 2 weeks, or have any known food allergies
• You have donated blood (more than 470 ml) in the past 30 days, or more than 50 ml of blood in the 2 weeks before screening
• You have tested positive for HIV
• You have tested positive for hepatitis B or C, unless it was caused by a vaccination
• You currently use drugs or have had a history of drug misuse within the past year
• You have a history of alcohol misuse or regularly drink more than 21 units of alcohol per week
• You have a mental health condition that prevents you from fully understanding what the study involves
• You are under legal guardianship or have restrictions on your freedom by administrative or legal order
• You are considered unlikely to follow the study rules, attend all required visits, or complete the study
• You are directly involved in running this study (for example, as a researcher, pharmacist, or staff member), or are a close relative of someone who is
• You have a known allergy to plants in the Acanthaceae family (confirm with trial site)
• You follow a vegetarian diet, due to the requirements of the standard meal used in this study

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