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Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib

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NCT06754761

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase
Phase 1
Status
Not yet recruiting
Study type
Interventional
Design
Na · None · Basic science
Enrollment
8estimated
Sites
2
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
DateFiledBasisWhat it is
Start2025-01-17estimatedWhen the study began enrolling
Primary completion2025-08-08estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-08-08estimatedThe whole study's end, after follow-up
First posted2025-01-01actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-01-01actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Neoplasm

Interventions

  • Drug: [14C] AZD6738
  • Drug: AZD6738 / ceralasertib

Primary outcomes

what the primary-completion date above is the date OF
To evaluate absolute bioavailability Ceralasertib and PK of Ceralasertib and [14C]-Ceralasertib after administration of oral dose of Ceralasertib and IV [14C]-Ceralasertib (Part A
measured Through end of Part A, approximately 5 weeks including screening period
To determine the rates and major excretory routes of Ceralasertib and its metabolites after IV dose of [14C]-Ceralasertib (Part A) and a oral dose of [14C]-Ceralasertib (Part B)
measured Through end of Part B, approximately 10 weeks including screening period
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
measured Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
measured Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
measured Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
measured Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
measured Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
measured Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
measured Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
measured Through end of the part B, approximately 10 weeks (Including screening period)

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