A Study of Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]AZD4144

An Open-Label, Two-Cohort Study of Absorption, Distribution, Metabolism, Excretion (ADME) of [14C]AZD4144 Following a Single Oral and IV Dose to Healthy Male Participants

This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabeled with a small amount of carbon-14 so it can be tracked in the body.

This study will take place at one site in Nottingham, United Kingdom, and will enroll 2 groups of 8 healthy men aged 30-65 years.

This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.

This study will take place at one site in Nottingham, United Kingdom.

It is planned to enroll 2 groups of 8 healthy men aged 30-65 years.

Each group will take part in 1 treatment period and receive a single dose of radiolabelled test medicine, either by injection into a vein or as a liquid by mouth. They'll stay in the clinic for up to 10 nights, attend 2 outpatient visits, and take up to 7 weeks to finish the study.

Blood and urine samples will be collected to do safety tests. Blood, urine and faecal samples will be collected to measure the amount of test medicine and its breakdown products.

Inclusion Criteria:

• Healthy males aged 30 to 65 years inclusive
• BMI of 18.0 to 32.0 kg/m2 inclusive
• Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

Exclusion Criteria:

• History of any clinically important disease or disorder
• History or presence of clinically significant cardiovascular, renal, respiratory, gastrointestinal disease, or neurological or psychiatric disorder
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first dosing day
• Acute diarrhoea or constipation within 7 days of the first dosing day
• Participants who do not have suitable veins for multiple venepunctures/cannulation
• Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
• Any clinically significant abnormal findings in vital signs
• Any clinically significant abnormalities on 12-lead ECG
• Evidence of renal impairment
• Participants who have received any IMP in the last 90 days prior to the first dosing day
• Participants who have previously received AZD4144
• 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 radiolabelled ADME study in the last 12 months.
• Blood or plasma donation, or loss of more than 400 mL blood during the 3 months prior to the study.
• Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of the first dosing day
• Use of drugs or herbal medications with CYP3A4 enzyme-inducing properties such as St John's Wort or CYP3A4 inhibiting properties within 3 weeks of the first dosing day
• Current smokers or known or suspected history of alcohol or drug abuse
• Excessive intake of caffeine-containing drinks or food