Phase 1 Lung Cancer 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:

• Healthy Chinese men who are between 18 and 45 years old (inclusive) at the time of signing the consent form
• People with a body mass index (BMI) between 19 and 26 kg/m² and a body weight of at least 50 kg
• People who fully understand the study's purpose and requirements and are willing to sign a consent form voluntarily
• People who are able to communicate well with the research team and follow the study schedule as required
• People whose blood and urine samples show carbon-14 (a naturally occurring substance) levels within normal background environmental ranges at the screening stage

Who may not be able to join:

• People whose physical examination, blood tests, urine tests, heart tracing (ECG), chest X-ray, abdominal ultrasound, rectal examination, or other routine checks show results that the investigator considers clinically significant
• People whose heart rhythm measurement (specifically the QTcF interval) is greater than 450 milliseconds, or who have other ECG findings the investigator considers significant
• People who test positive for hepatitis B, hepatitis C, syphilis, or HIV
• People whose eye examination (including eye pressure and retinal checks) shows clinically significant abnormalities
• People who have taken medications that affect a liver enzyme called CYP3A4 within 30 days before screening
• People who have taken any prescription medicines, over-the-counter medicines, herbal products, or supplements (such as vitamins or calcium) within 14 days before screening
• People with a history of any serious illness affecting the heart, lungs, hormones, nerves, digestion, kidneys, blood, immune system, mental health, or metabolism that the investigator believes could affect the trial results
• People who have difficulty swallowing or who have had stomach, bowel, or gallbladder surgery that could affect how a medicine is absorbed
• People with a history of heart disease, heart failure, heart attack, abnormal heart rhythms, long QT syndrome, or a close family member who died suddenly of a heart condition at a young age
• People who have had major surgery within 6 months before screening, or whose surgical wound has not fully healed
• People with a history of allergies to two or more substances, or whom the investigator believes may be allergic to the study drug
• People with haemorrhoids or anal conditions involving regular bleeding, irritable bowel syndrome, or inflammatory bowel disease
• People who regularly experience constipation or diarrhoea
• People who drink heavily or regularly (more than 14 units of alcohol per week) within 6 months before screening, have a breath alcohol reading of 20 mg/dL or above at screening, or are unable to avoid alcohol during the trial
• People who smoke more than 5 cigarettes a day or regularly use nicotine products within 3 months before screening, or who are unable to avoid nicotine during the trial
• People who have used cannabis within 3 months before screening, used harder drugs such as amphetamines within 1 year before screening, or who test positive for drugs of abuse at screening
• People who regularly drink grapefruit juice or large amounts of tea, coffee, or other caffeinated drinks and are unable to stop during the study
• People who have taken part in a trial involving a radiolabelled drug within 1 year before screening, or a carbon-14 breath test within 3 months before screening
• People with a fear of needles or blood, difficulty having blood taken, or who are unable to tolerate injections into a vein
• People who have taken part in any other clinical trial within 3 months before screening
• People who have received a vaccine within 1 month before screening or who plan to be vaccinated during the study
• People who plan to father a child or donate sperm during the study or within 1 year after it ends, or who are unwilling to use strict contraception for themselves and their partners during the study and for 1 year afterward
• People who have lost or donated 400 mL or more of blood within 3 months before screening, or received a blood transfusion within 1 month before screening
• People whom the investigator considers unsuitable for any other reason

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