Phase 1 Leukaemia 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:

• People who have read, understood, and signed a written consent form before any study activities begin, and who understand the possible risks and side effects involved.
• Adults aged 18 to 55 years (inclusive) at the time of screening.
• People with a body mass index (a measure of body weight relative to height) between 18.0 and 32.0, and a body weight of 100 kg or less at screening.
• People considered medically healthy by the lead doctor, based on medical history and a physical examination with no concerning findings.
• People with blood pressure, pulse rate, and body temperature within specified normal ranges, measured after resting.
• People whose heart tracing (ECG) shows no significant abnormalities.
• Female participants who are not able to become pregnant — either due to surgical procedures (such as removal of the uterus, fallopian tubes, or ovaries) performed at least 6 weeks before screening, or because they have gone through menopause (no periods for 12 months without another medical cause, confirmed by a hormone blood test).
• Female participants who could become pregnant, provided they have a negative pregnancy test at screening and on the day before dosing, agree not to try to become pregnant or donate eggs for at least 30 days after the last dose, and agree to use adequate contraception (a condom used by the male partner combined with a highly effective contraceptive method) from consent through to at least 30 days after the last dose — unless they are in an exclusively same-sex relationship or are abstinent as a committed lifestyle choice.
• Male participants who agree not to donate sperm for at least 90 days after the last dose, and who agree to use a condom (combined with a highly effective contraceptive method) during sexual activity with a female partner who could become pregnant, from consent through to at least 90 days after the last dose.
• Male participants who, if their female partner cannot become pregnant or if they have a same-sex partner, agree to use a condom from consent through to at least 5 days after the last dose.
• People with suitable veins that allow blood to be taken easily.
• People who are willing and able to follow all study procedures and schedules.

Who may not be able to join:

• People with a history of severe allergic reactions (such as anaphylaxis) or other significant allergies that the lead doctor believes could interfere with participation.
• People with a current or past history of significant disease or disorder affecting the heart, lungs, liver, kidneys, blood, digestive system, hormones, immune system, skin, mental health, or nervous system — including any acute illness in the past 3 months — if the lead doctor considers it clinically relevant.
• People who have had surgery or been hospitalised in the 3 months before screening, or who have surgery planned during the study period.
• People with a history of cancer (malignant disease) in the last 10 years, with the exception of certain skin cancers that were fully removed by surgery with clear confirmed margins.
• People with a condition that significantly weakens the immune system, such as certain immune deficiency disorders.
• People with risk factors for a specific type of dangerous heart rhythm called torsade de pointes, including a family history of long QT syndrome or sudden cardiac death, or people with a known heart rhythm disorder.
• People with conditions affecting the stomach, intestines, liver (including Gilbert's syndrome), or kidneys that could affect how the body processes a drug.
• People whose liver function blood tests are elevated beyond a specified threshold above the normal range (confirm with trial site for exact values; the lead doctor may allow some exceptions at their discretion).
• People whose kidney function, as measured by a specific blood test formula, falls below a set threshold (confirm with trial site for exact values).
• People who test positive for HIV, hepatitis B, or hepatitis C at screening.
• People who test positive for drugs of abuse or alcohol at screening or on admission to the study site on the first day of dosing.
• People who regularly drink more than 10 standard alcoholic drinks per week, or more than 4 standard drinks on any single day (where one standard drink equals 10 g of pure alcohol — roughly 285 mL of regular beer, 100 mL of wine, or 30 mL of spirits).
• People who have smoked, used any nicotine replacement products, e-cigarettes, or marijuana within the 3 months before dosing, or who test positive for carbon monoxide at check-in (a positive carbon monoxide test at the initial screening visit alone is not automatically excluding — confirm with trial site).
• Female participants who are currently breastfeeding or plan to breastfeed from screening until at least 3 months after the dose (or longer, depending on the drug's half-life).
• People who are unable to swallow oral (tablet or capsule) medication.
• People who have taken any prescription or over-the-counter medications, herbal products, nutritional supplements, vitamins, minerals, or hormone supplements within 7 days (or 5 half-lives of the medication, whichever is longer) before dosing — with the exception of paracetamol at doses of up to 500 mg every 6 hours (maximum 2 g per day) for no more than 3 consecutive days in a week.
• People with a current infection requiring antibiotic, antifungal, antiparasitic, or antiviral medication taken within 10 days before dosing.
• People who have received an inactivated vaccine within 14 days, or a live vaccine within 30 days, before the study drug is given, or who plan to receive vaccines during the study.
• People who have taken medications that suppress or modify the immune system (such as corticosteroids, methotrexate, azathioprine, cyclosporine, or interferon) within 28 days (or 5 half-lives, whichever is longer) before dosing, or who would need to take them during the study.
• People who have donated blood or plasma within 30 days before dosing, lost more than 500 mL of blood in the 30 days before the first dose, or received a blood transfusion within the past year.
• People who have taken part in a clinical trial of an experimental drug or device within 30 days (or 5 half-lives of that drug, whichever is longer) before screening.
• People who, in the lead doctor's opinion, are unsuitable for any other reason, including being unlikely to follow the study requirements fully.

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