GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5004 and Absolute Bioavailability of AZD5004 in Healthy Male Participants

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-35•Male•Healthy volunteers

Primary endpoints

•Absolute bioavailability - Part 1•Amount of AZD5004 excreted (Ae) - Part 2•Amount of AZD5004 excreted expressed as a percentage of the dose administered

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06857695

Org study IDD7260C00010

Timeline

Milestones

Study first posted2025-03-04actual

Study start2025-03-06actual

Primary completion2025-05-05actual

Study completion2025-05-05actual

Last update posted2025-05-28actual

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age30 Years

Maximum age65 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•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)

Exclusion criteria

•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.

•Use of any prescribed or non-prescribed medication

•Current smokers or known or suspected history of alcohol or drug abuse.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

10 endpoints

Primary/protocol endpoint

Absolute bioavailability - Part 1

Time frame:Plasma sample collection from pre-dose to 110 hrs post-dose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Amount of AZD5004 excreted (Ae) - Part 2

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

descriptive

Primary/protocol endpoint

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

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

descriptive

Primary/protocol endpoint

Cumulative amount of AZD5004 excreted (CumAe) - Part 2

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

descriptive

Primary/protocol endpoint

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

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

percent change from baseline, descriptive

Secondary/protocol endpoint

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

Time frame: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

Cmax

concentration, descriptive

componentsCmax, Plasma concentration (steady state)

Secondary/protocol endpoint

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

Time frame: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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Blood:plasma concentration ratios - Part 2

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

ratio, descriptive

Secondary/protocol endpoint

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

Time frame:Through study duration, approximately 7 weeks

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.