AZD5305 hADME in Patients With Advanced Solid Malignancies
← catalyst calendarNCT06713369 · readout in 44 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Fortrea.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · 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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-04-02 | actual | When the study began enrolling |
| Primary completion | 2026-10-02 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-10-02 | estimated | The whole study's end, after follow-up |
| First posted | 2024-12-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Locally Advanced or Metastatic Solid Tumor
Interventions
- Drug: Saruparib (AZD5305) — also filed as Saruparib
- Drug: [14C]-AZD5305 microtracer — also filed as IV [14C]-Saruparib microtracer
- Drug: [14C]-AZD5305 (therapeutic dose) — also filed as IV [14C]-Saruparib (therapeutic dose)
Primary outcomes
what the primary-completion date above is the date OFAbsolute bioavailability (F) of Saruparib
measured Day 4
Total radioactivity recovery in urine and faeces
measured Day 8
Pharmacokinetics of Saruparib(Part B)
measured Day 8
PK parameters characterized by AUCinf
measured Day 4
Ratio of AUCinf of plasma Saruparib relative to AUCinf of metabolite
measured Day 4
Mass balance parameters as characterized by amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined)
measured Day 8
Amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the administered dose
measured Day 8
Pharmacokinetics of Saruparib(Part B)
measured Day 8
Pharmacokinetics of Saruparib(Part B)
measured Day 8
Pharmacokinetics of Saruparib(Part B)
measured Day 8
Pharmacokinetics of Saruparib(Part B)
measured Day 8
Pharmacokinetics of Saruparib(Part B)
measured Day 8
Pharmacokinetics of Saruparib(Part B)
measured Day 8
PK parameters characterized by AUClast
measured Day 4
PK parameters characterized by Cmax
measured Day 4
PK parameters characterized by tmax
measured Day 4
PK parameters characterized by t1/2(lambda)z
measured Day 4
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