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

AstraZeneca16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

[14C]AZD4144 Solution for InfusionDRUG

Intravenous, fasted

[14C]AZD4144 Oral SolutionDRUG

Oral, fasted

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Research Site

Ruddington, United Kingdom

Outcomes

Primary Outcomes

Amount of AZD4144 excreted (Ae)

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (Fe)

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faeces and all excreta

Time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Cumulative amount of AZD4144 excreted (CumAe)

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Cumulative amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (CumFe)

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Area under the curve (AUC) of circulating plasma total radioactivity (TR) accounting for 10% or more of the dose

Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating total radioactivity

Time frame: Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose

80% or more of the radioactivity recovered in excreta

Identification of greater than 80% of the radioactivity recovered in the urine and/or faeces

Time frame: Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose

Data from ClinicalTrials.gov

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