Phase 1 Lymphoma 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:

• Adults between 18 and 85 years of age at the time of giving consent.
• People in the healthy control group must have no significant medical conditions, with normal results across physical examination, blood tests, vital signs, and heart trace (ECG).
• People in the liver impairment group must have a long-term (at least 6 months), stable liver condition, documented as a specific severity level known as Child-Pugh B or C.
• People in the liver impairment group must have been on a stable set of medications for at least 2 weeks before the screening visit.
• People with type 2 diabetes may be included if their blood sugar control measure (HbA1c) is below 10%, and they have not had a severe blood sugar episode or hospital admission related to diabetes in the past 6 months.
• People who weigh at least 50 kg and have a body mass index (a height-to-weight measure) between 18 and 42.
• Both males and females (as assigned at birth) may be eligible, provided they follow specific contraception requirements as set out by local regulations — females of childbearing potential must have a negative pregnancy test and use two forms of contraception until 54 days after the last dose; males must use condoms and must not donate sperm until 54 days after the last dose.
• People who are willing and able to sign a written consent form, including a separate consent for an optional genetics sample if they choose to participate in that part.

Who may not be able to join:

Healthy controls:

• People who have any significant medical condition, or who have diabetes of any type.
• People whose blood test results show liver enzyme levels, blood cell counts, or clotting measures outside acceptable ranges (confirm with trial site for specific values).
• People whose resting blood pressure or heart rate falls outside the acceptable ranges set for this group (confirm with trial site for specific values).
• People whose heart trace (ECG) shows a specific electrical interval (QTcF) above 450 milliseconds, or any other significant heart rhythm concern.
• People with a history of serious allergic reactions or hypersensitivity.
• People who have had major surgery within the 30 days before joining.
• People with a history of pancreas inflammation, or whose pancreatic enzyme levels are more than twice the upper limit of normal.
• People with very high triglyceride (blood fat) levels above a set threshold.
• People with elevated calcitonin (a hormone) levels above a set threshold.
• People with severely low vitamin D levels.
• People with low calcium levels in their blood.
• People who test positive for HIV, hepatitis B, or hepatitis C, or who have had problems with drug or alcohol misuse within the past year.

People with liver impairment:

• People whose medical or psychological conditions are unstable, or whose other health conditions are not well controlled.
• People with significantly reduced kidney function, below a set threshold (confirm with trial site).
• People whose resting blood pressure or heart rate falls outside the acceptable ranges set for this group (confirm with trial site for specific values).
• People with very low platelet counts, low white blood cell counts, low haemoglobin (a measure of red blood cells), or an HbA1c of 10% or above.
• People who have had a procedure to treat bleeding veins in the oesophagus (banding) within the past 3 months, or any bleeding in the digestive tract within the past 6 months.
• People who require frequent procedures to drain fluid from the abdomen (more often than every 4 weeks), or who have had such a procedure within the past 30 days.
• People whose liver function has been changing or worsening during the screening period, or who have liver cancer.
• People whose liver condition is caused by an active infection or medication, or whose liver impairment is the result of a condition outside the liver itself.
• People with bile duct blockage or liver problems not related to liver tissue, or who have significant confusion or altered awareness linked to liver disease (Grade 2 or above).
• People who have received an organ transplant that is still functioning, or who are expected to receive one within 2 months, or who have previously had a surgical procedure to reroute blood around the liver (porto-systemic shunt or TIPS).
• People whose heart trace (ECG) shows a specific electrical interval (QTcF) above 480 milliseconds, or any other significant heart rhythm concern.
• People with elevated pancreatic enzymes, very high blood fat levels, elevated calcitonin, severely low vitamin D, or low ionised calcium levels.
• People who have had a cancer diagnosis within the past 10 years, with limited exceptions for certain treated skin cancers or cervical changes; people with a personal or close family history of a specific inherited hormone condition (MEN2) or a specific type of thyroid cancer; people with a significant problem affecting how the stomach empties.
• People who test positive for HIV, hepatitis B, or hepatitis C (though people with hepatitis B or C may still be considered if follow-up testing shows the virus is not active — confirm with trial site).
• People who have misused drugs or alcohol within the past year.

All participants:

• People who have taken part in a study involving a new, previously untested medicine within the past 30 days or within 5 times that medicine's duration in the body (whichever is longer), or who have previously been given the specific study medicines being tested in this trial (AZD9550 or AZD6234).
• Healthy controls who have used prescription medicines, non-prescription medicines, or supplements within 7 days (or 14 days for certain medicines) before the study intervention, unless the trial team determines these would not interfere; people currently using oral contraceptives or oestrogen hormone replacement therapy.
• People with liver impairment who are using weight-loss medicines (including GLP-1 type medicines), medicines that cause significant weight gain (such as long-term steroids or certain antipsychotic medicines), GLP-1 medicines for diabetes, medicines known to affect heart rhythm, or oral contraceptives used for contraception; certain medicines are restricted to specific conditions and doses (confirm with trial site).
• People who have already been enrolled and dosed in this trial previously; people who test positive for drugs of abuse or alcohol at screening (with some exceptions for prescribed medicines in the liver impairment group); people who have recently donated or received blood products above the amounts set in the study protocol; people who are employees of the trial organisation or close relatives of study staff; people considered unlikely to follow the study requirements, as assessed by the trial team.

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