Phase 1 Schizophrenia 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:

• Men aged 18 to 45 years old who weigh at least 50 kg, or women aged 18 to 60 years old who weigh at least 45 kg, with a body mass index (a height-to-weight ratio) between 19.0 and 26.0
• People whose general health check-ups, including physical examination, vital signs, blood tests, and heart tracing (ECG), come back normal or with no medically significant findings
• Male participants who are willing to use effective contraception during the study and for 3 months after it ends; female participants who are not able to become pregnant
• People who are able to understand and follow the study instructions and who have freely chosen to take part by signing a consent form

Who may not be able to join:

• People who have a current or past history of significant illness or organ dysfunction affecting the nervous system, heart, lungs, digestive system, kidneys, hormones, blood, eyes, or other areas, or who have a history of cancer or other conditions the trial doctors consider unsuitable
• People with a current or past history of mental health disorders, brain dysfunction, self-harm, or who are assessed by the trial doctor as being at risk of suicide
• People who have had surgery on their digestive system (such as stomach removal or bowel resection) or who have conditions that may significantly affect how the body processes a drug, or who have a history of urinary blockage, gastrointestinal ulcers, or gastrointestinal bleeding
• People with a known allergy to the ingredients in the trial drug or similar medicines, or who have a history of allergic conditions
• People who test positive for hepatitis B, hepatitis C, syphilis, or HIV
• People who have had surgery within the 3 months before screening, have not yet fully recovered from surgery, or have a planned surgery scheduled during the trial period
• People who have donated or lost 400 mL or more of blood in the 3 months before screening, or 200 mL or more in the month before screening, or who have received blood products in the 3 months before screening
• People who have taken any prescription medicines, over-the-counter medicines, vitamins, or herbal products in the 2 weeks before screening
• People who have used medicines that affect how the liver breaks down certain drugs (specific enzyme inducers or inhibitors) within 4 weeks — or 5 half-lives of the drug, whichever is longer — before screening
• People who have taken part in another clinical trial or received a trial drug within the 3 months before screening, or who are currently enrolled in another clinical trial
• People who tested positive on a smoke test, smoke more than 5 cigarettes per day, drink more than 5 cups of coffee or tea per day, or who are unable to stop these during the study — assessed over the 3 months before screening
• People who have had a pattern of heavy alcohol use in the year before screening, averaging more than 14 standard drinks per week, or who test positive on a breath alcohol test
• People with a history of drug misuse in the year before screening, or who test positive on a urine drug screen
• People who have a family history of sudden cardiac death in a relative who died suddenly before the age of 40
• People whose resting heart rate, blood pressure readings, or drop in blood pressure upon standing fall outside the acceptable ranges set by the trial (confirm with trial site for exact values)
• People whose heart tracing (ECG) shows abnormalities that the trial doctor considers clinically significant, including certain measurements of heart rhythm that exceed defined limits
• People whose blood test results for liver enzymes, kidney function markers, or prolactin levels are above the normal upper limit
• People who have special dietary requirements, difficulty swallowing, or who are unable to follow a standard diet during the trial
• People who are unwilling to avoid smoking, alcohol, caffeine-containing drinks, and intense exercise during the trial
• People who are directly involved in running this clinical trial
• People whom the trial doctors consider unsuitable for any other reason

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