A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Quotient Sciences.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
8actual
Sites
1
Country
United Kingdom
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-06 | actual | When the study began enrolling |
| Primary completion | 2025-05-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-05 | actual | The whole study's end, after follow-up |
| First posted | 2025-03-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants
Interventions
- Drug: AZD5004 film-coated tablet — also filed as AZD5004
- Drug: [14C]AZD5004 Solution for Infusion — also filed as [14C]AZD5004
- Drug: [14C]AZD5004 Oral Solution — also filed as [14C]AZD5004
Primary outcomes
what the primary-completion date above is the date OFAbsolute bioavailability - Part 1
measured Plasma sample collection from pre-dose to 110 hrs post-dose
Amount of AZD5004 excreted (Ae) - Part 2
measured 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
measured Urine and faecal samples collected from pre-dose until 168 hours post dose
Cumulative amount of AZD5004 excreted (CumAe) - Part 2
measured 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
measured Urine and faecal samples collected from pre-dose until 168 hours post dose
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