Phase 1 Macular Degeneration 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 a healthy person between 18 and 55 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); and your body mass index (BMI) is between 19.0 and 28.0
• If you could become pregnant, or if you are male, you must agree to use effective birth control from before the study starts until 6 months after the last dose, with no plans to become pregnant or donate sperm or eggs during that time; if you could become pregnant, a pregnancy blood test before the first dose must come back negative
• You have no history of serious illnesses, and your physical check-up, heart tracing (ECG), chest X-ray, and blood/urine tests during screening are normal or only slightly outside normal in a way the doctor considers unimportant
• You are willing and able to follow all study instructions and sign a consent form agreeing to take part

Who may not be able to join:

• You have had a significant illness or health problem in the week before screening, or have one currently
• You have had a digestive system disease in the past 3 months that affects how your body absorbs fat-soluble vitamins, or have one currently
• You have had a condition related to vitamin A deficiency in the past 3 months, or have one currently
• You develop an acute (sudden) illness between screening and the first dose that the doctor thinks could affect the study results
• You have a history of serious problems with your vision, eyes, or retina
• You have difficulty swallowing
• You are known or suspected to be allergic to the study drug or any of its ingredients, or you have a history of significant allergies or allergic conditions (as judged by the doctor)
• You have had surgery in the past 3 months that the doctor thinks may affect how the drug moves through your body, or you have serious lasting effects from surgery, or you plan to have surgery during the study
• You have donated blood, lost a large amount of blood (400 mL or more), donated 2 or more units of blood components, or received a blood transfusion in the 3 months before the first dose; or you plan to donate blood during the study
• You have taken part in another clinical trial or received an experimental drug within 3 months before the first dose
• You have smoked more than 5 cigarettes a day on average in the past 3 months, or you are unable to avoid all tobacco products during the study
• You have drunk more than 14 units of alcohol per week on average in the past 3 months, cannot avoid all alcohol during the study, or have a positive breath alcohol test before the first dose
• You have regularly consumed large amounts of tea, coffee, or caffeinated drinks in the past 3 months, or cannot avoid these during the study
• You have taken any prescription medicines, over-the-counter medicines, herbal medicines, vitamins, or health supplements within 28 days before screening (or within 5 half-lives of the medicine, whichever comes first)
• Your heart tracing (ECG) during screening shows certain abnormal readings in the electrical activity of your heart (confirm with trial site)
• You are pregnant or breastfeeding, or a pregnancy blood test comes back positive before the first dose
• You test positive for certain infections including hepatitis B, hepatitis C, HIV, or syphilis, in a way the doctor considers clinically significant
• You test positive on a urine drug screen, or you have a history of drug misuse or drug use in the past 5 years
• You have eaten or drunk pitaya (dragon fruit), mango, grapefruit, starfruit, or foods/drinks made from these fruits, or consumed anything containing xanthine, caffeine, or alcohol, within 72 hours before the first dose
• You have special dietary needs, are lactose intolerant, or are unable to follow the standard diet provided during the study
• The doctor running the study decides for any other reason that you are not suitable to take part

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