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NCT07812077

A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved 3 months later.

See at-risk trials from AstraZeneca

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Record History

All 2 versions: 2 with changes below.

  1. Recruitment opened
    • Primary and study completion pushed from Dec 17, 2026 to Mar 17, 2027
    • Study sites: 0 to 1
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Amount of AZD4954 excreted (Ae) (Part 1)
Timeframe: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Amount of AZD4954 excreted expressed as a fraction of dose excreted (Fe) (Part 1)
Timeframe: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Cumulative amount of AZD4954 excreted (CumAe) (Part 1)
Timeframe: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Cumulative amount of AZD4954 excreted expressed as a fraction of dose excreted (CumFe) (Part 1)
Timeframe: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Absolute bioavailability (F) based on AUC0-inf (Part 2)
Timeframe: Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose

Secondary (7)

Maximum observed concentration (Cmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Time of maximum observed concentration (Tmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4954 and total radioactivity (Parts 1 and 2)
Terminal elimination half-life (T1/2) for AZD4954 and total radioactivity (Parts 1 and 2)
Area under the curve (AUC) of circulating total radioactivity accounting for 10% or more of the dose (Part 1)
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80% or more of the radioactivity recovered in excreta (Part 1)
Disposition of total radioactivity in plasma and in blood (Part 1)

Arms and interventions

Part 1Experimental

Participants in Part 1 will receive a single dose of \[14C\]AZD4954 Oral Solution.

Part 2Experimental

Participants in Part 2 will receive a single unlabelled oral dose of AZD4954 tablet and a radiolabelled IV microtracer dose of \[14C\]AZD4954.

Drugs: [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet, [14C]AZD4954 Solution for Infusion

Sites

1 site in 1 country

  • Research SiteRuddington, United Kingdom