Phase 1 Psoriasis 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 are able to fully understand what the trial involves, including possible side effects, are willing to complete the study, and are able to sign a consent form.
• Adults between 18 and 70 years old (inclusive).
• Male participants who weigh at least 50 kg, and female participants who weigh at least 45 kg, with a body mass index (BMI) between 19 and 32 kg/m².
• People with chronic (long-term), stable liver damage caused by a primary liver disease (such as autoimmune hepatitis, non-alcoholic fatty liver disease, or alcoholic liver disease), where the condition has been stable for at least 28 days before taking the study drug (or at least 14 days for those with moderate liver impairment).
• People whose liver impairment has been graded as mild (Child-Pugh score 5–6) or moderate (Child-Pugh score 7–9) within 72 hours before taking the study drug, based on a standard medical assessment.
• People who have been on a stable medication plan for their liver condition and any related complications for at least 28 days (or 14 days for moderate liver impairment) before taking the study drug, with no changes needed to their medications — or people who are not taking any medications for these conditions.
• People who are otherwise in good general health aside from their liver condition, as confirmed through medical history, physical examination, blood tests, heart tracings, and other standard health checks.

Who may not be able to join:

• People who have previously had a liver transplant, severe high blood pressure in the liver's blood vessels, a surgical shunt around the liver, suspected or confirmed liver cancer or other cancers, hepatorenal syndrome (kidney failure related to liver disease), or serious conditions affecting bile flow (such as biliary cirrhosis or bile duct obstruction).
• People with serious complications such as brain problems related to liver disease (hepatic encephalopathy), liver failure, bleeding from enlarged veins in the oesophagus or stomach, or severe fluid build-up requiring drainage and albumin treatment, where the trial doctor considers participation unsuitable.
• People who, in addition to their liver condition, have had serious illness affecting other major organs (such as the nervous system, digestive system, lungs, kidneys, hormonal system, blood, or immune system) within the past year, if the trial doctor considers this makes participation unsuitable.
• People who, within the 6 months before joining, have experienced a heart attack, certain serious heart rhythm problems (including long QT syndrome, a specific type of dangerous fast heart rhythm, or bifascicular block), unstable chest pain, heart bypass surgery, severe heart failure (NYHA class III or IV), stroke, mini-stroke (TIA), or a blood clot in the lungs.
• People with a history of depression or suicidal thoughts.
• People who have had severe digestive system disease (not caused by their liver condition) or digestive surgery within 3 months before screening, where the trial doctor believes this could affect how the study drug is absorbed.
• People who lost more than 400 mL of blood, donated blood, or received a red blood cell transfusion in the month before screening.
• People whose liver condition is currently fluctuating or worsening (for example, active hepatitis, advancing fluid build-up, fever, or active bleeding in the digestive tract), or who have ongoing heart rhythm problems or atrial fibrillation at screening.
• People whose blood test results at screening show: liver enzyme (ALT) levels more than 5 times the upper limit of normal; very low white blood cell count (neutrophils below 1.0×10⁹/L); low haemoglobin (below 90 g/L); low platelet count (below 50×10⁹/L); or elevated liver tumour marker (AFP above 50 ng/mL) with suspected liver cancer.
• People with a history of specific allergic conditions (such as asthma, hives, or eczema), a known tendency to be allergic to multiple drugs, foods, or pollens, or a known allergy to a class of medicines called PDE4 inhibitors (such as apremilast or roflumilast).
• People who have had a history of drug abuse in the past 5 years or illegal drug use in the past 3 years before screening.
• People who test positive for drug abuse at screening (unless the positive result is clearly due to an approved medication being taken).
• People who test positive for alcohol on a breath test at screening.
• People who have consumed more than 14 units of alcohol per week in the 3 months before screening, or who are unable to avoid alcohol during the study (1 unit is approximately 354 mL of 5% beer, 44 mL of 40% spirits, or 147 mL of 12% wine).
• People who have smoked more than 5 cigarettes per day in the 3 months before screening, or who are unable to stop using all tobacco products during the study.
• People who have regularly consumed more than 8 cups (250 mL each) of tea, coffee, or other high-caffeine drinks per day in the past 3 months.
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis in a clinically significant way.
• People who have taken part in another clinical trial and used a trial drug or device within 3 months before screening.
• People who have taken medicines known to be potentially harmful to the liver (such as paracetamol/acetaminophen, certain antibiotics, antifungals, or cholesterol-lowering drugs) for 7 or more consecutive days within the 3 months before screening.
• People who have used medicines that significantly affect how the liver processes drugs — either speeding up or slowing down this process — within 30 days before screening (confirm with trial site for the specific medicines involved).
• People who have used prescription medicines, over-the-counter medicines, health supplements, herbal products, or vaccines (other than those already being taken for their liver condition and related illnesses) within the 2 weeks before screening.
• People who are unable to avoid caffeine-containing or other specified foods and drinks (such as strong tea, coffee, chocolate, cola, grapefruit, dragon fruit, or mango) from the time of screening until admission to the trial site (confirm with trial site for full list).
• People who are pregnant or breastfeeding, or people of any sex who plan to conceive a child or donate sperm or eggs from two weeks before the trial until six months after the last dose, and who are unwilling or unable to use effective contraception during this time.
• People who are unable to eat normally, have difficulty swallowing, or have special dietary needs that prevent them from following the standard diet required by the trial.
• People with a history of epileptic seizures.
• People who are unable to tolerate having blood drawn through a needle, or who have a history of fainting at the sight of blood or needles.
• People whom the trial doctor considers unsuitable for any other reason.

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