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

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: [14C]AZD4144 Solution for Infusion, [14C]AZD4144 Oral Solution

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 30 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Ruddington, United Kingdom