Study S003264

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT06857695
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 8
Start: 2025-03-06
Primary completion: 2025-05-05
Lead sponsor: AstraZeneca
Conditions: Healthy Participants
Interventions: DRUG:AZD5004 film-coated tablet; DRUG:[14C]AZD5004 Solution for Infusion; DRUG:[14C]AZD5004 Oral Solution
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Absolute bioavailability - Part 1 [Plasma sample collection from pre-dose to 110 hrs post-dose]
Amount of AZD5004 excreted (Ae) - Part 2 [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 [Urine and faecal samples collected from pre-dose until 168 hours post dose]
Cumulative amount of AZD5004 excreted (CumAe) - Part 2 [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 [Urine and faecal samples collected from pre-dose until 168 hours post dose]

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