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AZD5004 film-coated

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: May 28, 2025

AZD5004 film-coated target and mechanism

ModalitySmall molecule

Also known as AZD5004 film-coated tablet

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

AZD5004 film-coated clinical trials

AZD5004 film-coated · 1 trial · 1 indication

Phase 1 1
NCT06857695A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004Healthy Participants
COMPLETED8 Analytics
PHASE1COMPLETED
A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004
Healthy ParticipantsUnlock trial analytics

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 to 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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Frequently asked questions about AZD5004 film-coated

What is AZD5004 film-coated?

AZD5004 film-coated is an investigational small molecule developed by AstraZeneca PLC. It is in Phase 1 clinical development, and no therapeutic indication has been disclosed for it. The film-coated tablet form refers to the oral formulation studied in its clinical program.

Who makes AZD5004 film-coated?

AZD5004 film-coated is made by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the developer responsible for the clinical program evaluating this small molecule.

What phase is AZD5004 film-coated in?

AZD5004 film-coated is in Phase 1 clinical development. It is an investigational agent and is not approved for any indication. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is AZD5004 film-coated in?

AZD5004 film-coated has been studied in one completed Phase 1 trial, NCT06857695, titled A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004. The trial enrolled 8 healthy male participants aged 30 years and older in the United Kingdom.

Is AZD5004 film-coated the same as AZD5004 film-coated tablet?

Yes, AZD5004 film-coated tablet is another name for AZD5004 film-coated. Both refer to the same AstraZeneca small molecule in Phase 1 development, so searches using either name point to the same investigational asset.

What is known about the AZD5004 film-coated Phase 1 trial design?

The completed Phase 1 trial NCT06857695 was an uncontrolled study with no randomization or blinding. It enrolled 8 healthy male volunteers aged 30 years and older in the United Kingdom and assessed mass balance, ADME, and absolute bioavailability of AZD5004.