A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004

NCT06857695 | Completed Phase 1

• 1 other identifier: D7260C00010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study in healthy volunteers aims to answer these questions:

• Does the test medicine cause any important side effects?
• What are the blood levels of the test medicine and how quickly does the body get rid of it?
• How much of the test medicine taken by mouth gets into the bloodstream?
• How does the body break down and get rid of the test medicine? This study will take place at one site in Nottingham, United Kingdom, and plans to enrol 8 healthy men aged 30-65 years, who will be involved in both parts of the study.

Conditions

Healthy Participants

Keywords

Healthy Participants

Outcome Measures

Primary Outcomes (5)

• Absolute bioavailability - Part 1

  Absolute bioavailability (F) based on AUC0-inf of oral and IV administration, adjusted for dose

  Plasma sample collection from pre-dose to 110 hrs post-dose

• Amount of AZD5004 excreted (Ae) - Part 2

  Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)

  Urine and faecal samples collected from pre-dose until 168 hours post-dose

• Amount of AZD5004 excreted expressed as a percentage of the dose administered (Fe) - Part 2

  Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)

  Urine and faecal samples collected from pre-dose until 168 hours post dose

• Cumulative amount of AZD5004 excreted (CumAe) - Part 2

  Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)

  Urine and faecal samples collected from pre-dose until 168 hours post dose

• Cumulative amount of AZD5004 excreted expressed as a percentage of the dose administered (CumFe) - Part 2

  Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)

  Urine and faecal samples collected from pre-dose until 168 hours post dose

Secondary Outcomes (5)

• Maximum observed concentration (Cmax) for AZD5004 and total radioactivity (TR) - Part 1 and Part 2

  Plasma sample collection from pre-dose to 110 hours post-dose in Part 1 and from pre-dose to 168 hours post-dose in Part 2

• Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5004 - Part 1 and Part 2

  Plasma sample collection from pre-dose to 110 hours post-dose in Part 1 and from pre-dose to 168 hours post-dose in Part 2

• Area under the curve (AUC) of circulating plasma total radioactivity (TR) or accounting for 10% or more of the dose in excreta - Part 2

  Plasma, urine and faecal samples from pre-dose until 168 hours post-dose

• Blood:plasma concentration ratios - Part 2

  Whole blood and plasma samples collected from pre-dose until 168 hoours post-dose

• Number of subjects with treatment-related adverse events - Part 1 and 2

  Through study duration, approximately 7 weeks

Study Arms (1)

AZD5004

EXPERIMENTAL

A single dose of AZD5004 film-coated tablet and a single dose of \[14C\]AZD5004 Solution for Infusion (Part 1) A single dose of \[14C\]AZD5004 Oral Solution (Part 2)

Drug: AZD5004 film-coated tablet; Drug: [14C]AZD5004 Solution for Infusion; Drug: [14C]AZD5004 Oral Solution

Interventions

AZD5004 film-coated tablet DRUG

oral, fasted

Also known as: AZD5004

AZD5004

[14C]AZD5004 Solution for Infusion DRUG

intravenous, fasted

Also known as: [14C]AZD5004

AZD5004

[14C]AZD5004 Oral Solution DRUG

oral, fasted

Also known as: [14C]AZD5004

AZD5004

Eligibility Criteria

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

You may qualify if:

• Healthy males aged 30 to 65 years inclusive
• BMI in the range 18.0 - 35.0 kg/m2 and body weight ≥63 kg
• Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

You may not qualify if:

• History of any clinically significant disease or disorder
• History or presence of clinically significant gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
• Excessive intake of caffeine containing drinks or food
• History/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
• Uncontrolled thyroid disease
• History of acute pancreatitis or gallstones
• Serum triglyceride concentrations \> 1000 mg/dL (11 mmol/L)
• Any history of significant inflammatory bowel disease, gastroparesis, or other severe disease or prior surgery affecting the upper GI tract
• Participants who do not have suitable veins for multiple venepunctures/cannulation
• Clinically significant abnormal clinical chemistry, haematology or urinalysis
• Significant hepatic disease
• Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG
• Abnormal renal function
• 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 \[14C\] ADME study in the last 12 months.

Sponsors & Collaborators

• AstraZeneca: lead
• Quotient Sciences: collaborator

Study Sites (1)

Research Site

Ruddington, NG11 6JS, United Kingdom

Location

Study Officials

• Sharan Sidhu, MBChB, BAO, MRCS, MFPM

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 6, 2025
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

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 refer 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 participant-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)