A Trial to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD9550 and AZD6234

Korábbi kezelés

• Prior or planned bariatric surgery or placement of a weight loss device
• Participants who have received any IMP in the last 90 days prior to dosing
• Participants who have previously received AZD9550 and/or AZD6234
• Treatment with prescription or non-prescription medication intended for weight loss within 3 months before screening
• Treatment with a GLP-1-containing preparation within 3 months before screening
• Treatment with an amylin analogue containing preparation within 30 days before screening
• Treatment with medication for diabetes within 3 months before screening
• Treatment with medication associated with significant weight gain in the 3 months before screening
• Plasma donation within 3 months of screening or any blood donation/loss more than 500 mL within 3 months before screening
• Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing
• Use of drugs or herbal medications with CYP3A4 enzyme-inducing properties within 3 weeks of dosing

Más betegség

• History of any clinically important disease or disorder
• History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or GI disorder including a history of pancreatitis or gall stones
• History of suicidal ideation or behaviour
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of dosing
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to any component of the AZD6234 or AZD9550 drug products
• Skin disorder/condition or tattoos in the abdominal area of the proposed injection site which can interfere with study assessments
• Evidence of renal impairment
• Current smokers or known or suspected history of alcohol or drug abuse

Laborértékek

• HbA1c ≥6.5% (≥48 mmol/mol)

Egyéb

• Participants who do not have suitable veins for multiple venepunctures/cannulation
• Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
• Basal calcitonin level > 50 ng/L
• Any clinically significant abnormal findings in vital signs
• Any clinically significant abnormalities on 12-lead ECG
• Females who are pregnant or lactating
• Excessive intake of caffeine-containing drinks or food

• Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive
• BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg