A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954

An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and Absolute Bioavailability of AZD4954 in 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 radiolabelled with a small amount of carbon-14 so it can be tracked in the body.

This two-part study will take place at one site in Nottingham, United Kingdom, and will enroll 8 healthy men in each part, 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 8 healthy male participants in each part, aged 30-65 years.

In part 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth. They'll stay in the clinic for up to 24 nights, attend 1 outpatient visit, and take up to 8 weeks to finish the study.

In part 2 volunteers will receive a single dose of test medicine by mouth and, shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein. They'll stay in the clinic for up to 15 nights, attend 1 outpatient visit, 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 35.0 kg/m2 inclusive
• Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

Exclusion Criteria:

• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
• Presence or history of clinically significant allergy requiring treatment
• History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder
• History of cholecystectomy or gall stones
• History of GI surgery
• Acute diarrhoea or constipation in the 7 days before the predicted Day 1
• Participants who do not have suitable veins for multiple venepunctures/cannulation
• Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
• Evidence of renal impairment at screening
• Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1
• Participants who have previously been administered IMP in this study
• Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
• Participants who have been administered IMP in an ADME study in the last 12 months
• Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
• 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
• Current smokers or known or suspected history of alcohol or drug abuse
• Excessive intake of caffeine-containing drinks or food