Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

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

Who might be able to join this trial:

• You are willing to take part voluntarily and are able to sign a consent form after fully understanding what the trial involves
• You are between 18 and 45 years old (inclusive)
• If you are male, you weigh at least 50 kg (about 110 lbs); if you are female, you weigh at least 45 kg (about 99 lbs)
• Your Body Mass Index (BMI) is between 18 and 28 kg/m²
• You are willing and able to use effective birth control (such as abstinence, condoms, an IUD, or a combination of barrier methods) from the start of screening until 6 months after your last dose of the trial drug
• Your vital signs (such as blood pressure and heart rate) and physical exam results are normal or only slightly abnormal in a way that is not medically concerning

Who may not be able to join:

• You have a history of drug allergies, specific allergic conditions (such as asthma or hives), or a known or suspected allergy to the trial drug or its ingredients
• You have taken any prescription medicines, over-the-counter medicines, herbal remedies, or health supplements in the 2 weeks before screening
• Your lab tests, ultrasound, chest X-ray, or other medical checks show results that are considered clinically significant concerns, or you have had a significant medical condition in the past 6 months (including but not limited to conditions affecting the gut, kidneys, liver, nerves, blood, hormones, lungs, immune system, mental health, or heart and blood vessels)
• You ate certain foods that can affect how the body processes medicines (such as grapefruit, dragon fruit, or mango) within 7 days before screening, or did intense exercise during that time
• You or a close blood relative (parent, sibling, or child) has a history of certain heart rhythm problems, long or short QT syndrome, unexplained sudden death before age 40, or sudden infant death syndrome
• You have abnormal levels of certain minerals in your blood (such as potassium, magnesium, or calcium) that are considered clinically significant
• You have a clinically significant abnormal heart tracing (ECG), or a specific heart rhythm measurement (QTcF) greater than 450ms
• Your kidney function, as measured by a specific calculation, falls below a certain level (confirm with trial site)
• You have or have had a chronic or active digestive condition, such as stomach ulcers, esophageal disease, intestinal inflammation, active gastrointestinal bleeding, or relevant gastrointestinal surgery
• You had a major surgery (not including diagnostic procedures) in the 6 months before screening, are planning surgery during the study, or had surgery that may affect how your body handles medicines
• You took part in another clinical trial within the 3 months before screening and actually received the trial drug in that study
• You donated blood or lost a significant amount of blood (more than 450 ml) in the 3 months before screening
• You have a history of heavy alcohol use (averaging more than 14 units per week in the past 3 months), are unable to avoid alcohol during the trial, or test positive on a breath alcohol test
• You smoked more than 5 cigarettes per day on average in the 3 months before screening
• You have a history of drug or substance abuse, or test positive on a urine drug screening
• You have specific dietary requirements that would prevent you from following the trial's standard meal plan
• You have difficulty swallowing
• You are currently breastfeeding or have a positive pregnancy test result
• You became acutely unwell or started taking new medication between your screening visit and the time you would take the first trial drug dose
• You consumed chocolate, caffeine, or foods or drinks rich in xanthines in the 24 hours before taking the first trial drug dose
• You consumed any alcohol-containing product or tested positive on a breath alcohol test in the 24 hours before taking the trial drug
• The trial doctor believes, for any other reason, that you are not suitable to take part

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