NCT07518459

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	[14C]AZD4144 Solution for Infusion	Intravenous, fasted
DRUG	[14C]AZD4144 Oral Solution	Oral, fasted

Timeline

• Start date: 2026-02-11
• Primary completion: 2026-05-28
• Completion: 2026-05-28
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: United Kingdom