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AZD5004 film-coated

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: May 28, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06857695A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004PHASE1 COMPLETED 8 — — Mar 6, 2025May 5, 2025May 28, 20251 United Kingdom
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Study Endpoints
Primary Endpoints
Absolute bioavailability - Part 1
Plasma sample collection from pre-dose to 110 hrs post-dose

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

Amount of AZD5004 excreted (Ae) - Part 2
Urine and faecal samples collected from pre-dose until 168 hours post-dose

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

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

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

Cumulative amount of AZD5004 excreted (CumAe) - Part 2
Urine and faecal samples collected from pre-dose until 168 hours post dose

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

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

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

Secondary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD5004EXPERIMENTALA 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)
Interventions
NameTypeDescription
AZD5004 film-coated tabletDRUGoral, fasted
[14C]AZD5004 Solution for InfusionDRUGintravenous, fasted
[14C]AZD5004 Oral SolutionDRUGoral, fasted
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Eligibility Criteria
Age Range30 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 * His...

Countries:United Kingdom
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