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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: [14C]AZD4144 Solution for Infusion; Drug: [14C]AZD4144 Oral Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Ruddington, United Kingdom, NG11 6JS
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regimen A; Participants in Cohort 1 will receive a single intravenous injection of [14C]AZD4144 Solution for Infusion	Drug: [14C]AZD4144 Solution for Infusion; Intravenous, fasted; Other Names: AZD4144
Experimental: Regimen B; Participants in Cohort 2 will receive a single oral dose of [14C]AZD4144 Oral Solution	Drug: [14C]AZD4144 Oral Solution; Oral, fasted; Other Names: AZD4144

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of maximum observed concentration (tmax) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Maximum observed concentration (Cmax) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Terminal elimination half-life (T1/2) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Apparent volume of distribution at steady state after a single IV administration (Vss) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Total body clearance calculated after a single IV administration (CL) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Renal clearance calculated using plasma AUC (CLR) for AZD4144 and total radioactivity	The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood	Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Whole blood:plasma concentration ratios	Whole blood:plasma concentration ratios for total radioactivity	Whole blood and plasma samples collected from pre-dose until 168 hours post-dose
Absolute bioavailability	Absolute bioavailability (F) of AZD4144 based on AUC0-inf	Plasma samples collected from pre-dose until 168 hours post-dose

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Quotient Sciences
• Investigators: Principal Investigator: Sharan Sidhu, MBChB, BAO, Quotient Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 28, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy participants
• Other Study ID Numbers: D9440C00005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No