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

NCT07518459 | Completed Phase 1

• 1 other identifier: D9440C00005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Healthy participants

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (11)

• Time of maximum observed concentration (tmax) for AZD4144 and total radioactivity

  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

  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

  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

  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

  Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose

Study Arms (2)

Regimen A

EXPERIMENTAL

Participants in Cohort 1 will receive a single intravenous injection of \[14C\]AZD4144 Solution for Infusion

Drug: [14C]AZD4144 Solution for Infusion

Regimen B

EXPERIMENTAL

Participants in Cohort 2 will receive a single oral dose of \[14C\]AZD4144 Oral Solution

Drug: [14C]AZD4144 Oral Solution

Interventions

[14C]AZD4144 Solution for Infusion DRUG

Intravenous, fasted

Also known as: AZD4144

Regimen A

[14C]AZD4144 Oral Solution DRUG

Oral, fasted

Also known as: AZD4144

Regimen B

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Quotient Sciences: collaborator

Study Sites (1)

Research Site

Ruddington, NG11 6JS, United Kingdom

Location

Study Officials

• Sharan Sidhu, MBChB, BAO

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohorts 1 and 2 are each single arm regimens

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: April 8, 2026
• Study Start: February 11, 2026
• Primary Completion: May 26, 2026
• Study Completion: May 26, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

GB (1)