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Sponsor: AstraZeneca
Conditions: Healthy Participants
Interventions: AZD5004 film-coated tablet, [14C]AZD5004 Solution for Infusion, [14C]AZD5004 Oral Solution
Countries: United Kingdom
This study in healthy volunteers aims to answer these questions: * Does the test medicine cause any important side effects? * What are the blood levels of the test medicine and how quickly does the body get rid of it? * How much of the test medicine taken by mouth gets into the bloodstream? * How does the body break down and get rid of the test medicine? This study will take place at one site in Nottingham, United Kingdom, and plans to enrol 8 healthy men aged 30-65 years, who will be involved in both parts of the study.
Sex: MALE
Age: 30 Years to 65 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Healthy males aged 30 to 65 years inclusive * BMI in the range 18.0 - 35.0 kg/m2 and body weight ≥63 kg * Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: * History of any clinically significant disease or disorder * History or presence of clinically significant gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity * Excessive intake of caffeine containing drinks or food * History/family history of medullary thyroid carcinoma or multiple endocrine neoplasia * Uncontrolled thyroid disease * History of acute pancreatitis or gallstones * Serum triglyceride concentrations \> 1000 mg/dL (11 mmol/L) * Any history of significant inflammatory bowel disease, gastroparesis, or other severe disease or prior surgery affecting the upper GI tract * Participants who do not have suitable veins for multiple venepunctures/cannulation * Clinically significant abnormal clinical chemistry, haematology or urinalysis * Significant hepatic disease * Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG * Abnormal renal function * Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years, occupationally exposed worker, or have been administered IMP in a \[14C\] ADME study in the last 12 months. * Use of any prescribed or non-prescribed medication * Current smokers or known or suspected history of alcohol or drug abuse.
- Ruddington, United Kingdom