Phase 1 Stroke Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to read and understand the consent form, and who are willing to sign it
• Men and women between 18 and 65 years old (inclusive) at the time of signing the consent form
• People with no significant past or current health problems affecting the heart, liver, kidneys, digestive system, nervous system, lungs, eyes, mental health, or metabolism, as assessed by the study doctor
• People confirmed to be in good health based on medical history, physical checks, lab tests, and a heart tracing (ECG)
• People with a body mass index (BMI) between 18.0 and 32.0, and a body weight of at least 50 kg, at the time of screening and the day before dosing
• People who agree to use contraception methods approved by the study doctor throughout the trial
• People with normal kidney function (confirmed by a specific blood test result) at screening and the day before dosing
• People who are able to swallow and keep down oral medication
• People who show no signs of suicidal thoughts, as measured by a standard assessment tool (C-SSRS), at screening and the day before dosing

Who may not be able to join:

• People with a known allergy or sensitivity to the study drug LWP779 or any of its ingredients
• People with a known or suspected tumour
• People with a history of unexplained fainting, low blood pressure with symptoms, or low blood sugar episodes
• People whose blood pressure drops significantly when standing up, detected at screening or the day before dosing
• People with any eye condition (such as glaucoma, macular degeneration, corneal problems, or retinopathy)
• People with a family history of a heart condition called long QT syndrome, or whose heart tracing (ECG) shows certain abnormalities at screening or the day before dosing
• People whose resting heart rate is below 45 or above 100 beats per minute at screening or the day before dosing
• People whose blood pressure readings fall outside acceptable ranges at screening or the day before dosing
• People with a history of unstable heart disease, a heart attack within the past 6 months, or a significant heart rhythm problem
• People with ongoing liver disease or abnormal liver blood test results at screening or the day before dosing, including those with a condition called Gilbert's syndrome
• People with a history of chronic diarrhoea, poor nutrient absorption, unexplained weight loss, or significant food allergies or intolerances, as assessed by the study doctor
• People with a history of bleeding in the brain, stroke, or blood vessel disease in the brain
• People with any condition or history that may increase the risk of bleeding, as assessed by the study doctor
• People who have regularly used blood-thinning or clot-dissolving medications in the 3 months before screening
• People with conditions that may make routine blood collection difficult, as assessed by the study doctor
• People who test positive for HIV, hepatitis B, or hepatitis C at screening
• People who have donated or lost more than 500 mL of blood in the 3 months before screening, donated bone marrow or stem cells within 90 days before the first dose, or donated plasma within 30 days before the first dose
• People who have taken part in another clinical drug trial within the past 3 months or 5 half-lives of that drug (whichever is longer), or a medical device trial within the past 3 months
• People who have previously received the study drug LWP779
• People who have used certain prescription medicines, vaccines, or drugs that interact with specific liver enzymes (CYP3A4/5 or P-glycoprotein) within 30 days or 5 half-lives before the first dose (whichever is longer)
• People who have used over-the-counter medicines, vitamins, supplements, or herbal products within 14 days or 5 half-lives before the first dose, if the study doctor considers these may affect the trial (paracetamol is allowed up to a maximum of 2000 mg per day)
• People who have been admitted to hospital or had major surgery within 6 months before screening, or who have had weight-loss (bariatric) surgery at any time
• People with a history of misusing prescription drugs, or who test positive on a urine drug screen at screening or the day before dosing
• People who regularly drink more than 10 standard alcoholic drinks per week, or more than 4 on any single day (where one standard drink equals 10 g of pure alcohol)
• People who smoke or use nicotine products more than twice a week, or who are unwilling to stop using these for 7 days before the day prior to dosing through to the end of the study, or who test positive for nicotine (cotinine) the day before dosing
• People who have used cannabis or CBD products in any form within 30 days before the first dose
• People who are pregnant (confirmed by a pregnancy test at screening or the day before dosing) or who are breastfeeding
• People who have consumed food or drinks containing caffeine, alcohol, xanthine, or certain fruits (Seville orange, pomelo, dragon fruit, starfruit, guava, or grapefruit) within 48 hours before each visit to the clinical unit
• People who test positive for alcohol at screening or the day before dosing
• People who are employees or family members of the study doctor, study site staff, or the trial sponsor
• People unwilling to eat a specific high-fat meal (eggs, bacon, butter, white bread, and full cream milk) — this applies to the Food Effect part of the study only
• People who are unable or unwilling to follow all study rules and requirements
• People who develop a new health condition during the screening period or before the first dose, or who have any other finding that the study doctor believes would put them or the study at risk

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