AZD5305 hADME in Patients With Advanced Solid Malignancies (NCT06713369) | Clinical Trial Compass
RecruitingPhase 1
AZD5305 hADME in Patients With Advanced Solid Malignancies
United Kingdom8 participantsStarted 2025-04-02
Plain-language summary
This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of \[14C\]-Saruparib in patients with advanced solid malignancies.
This will be done on an inpatient basis in 2 parts (single-dose oral administration with radiolabeled microtracer in Part A, single-dose IV radiolabeled administration in Part B) during which samples will be obtained of plasma, urine, feces and vomitus (where applicable).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF.
✓. Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable.
✓. ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to dosing.
✓. Predicted life expectancy ≥ 12 weeks.
✓. Adequate organ and marrow function as defined in the protocol
✓. Willingness and ability to comply with study and follow-up procedures.
✓. Able and willing to stay in hospital for specified residential periods following administration of Saruparib/\[14C\]-Saruparib
✓. Regular bowel movements
Exclusion criteria
✕. Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). Specific screening for MDS/AML is not required.
✕. Participants with any known predisposition to bleeding
✕. Any history of persisting severe cytopenia due to any cause
✕. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of Saruparib.
What they're measuring
1
Absolute bioavailability (F) of Saruparib
Timeframe: Day 4
2
Total radioactivity recovery in urine and faeces
Timeframe: Day 8
3
Pharmacokinetics of Saruparib(Part B)
Timeframe: Day 8
4
PK parameters characterized by AUCinf
Timeframe: Day 4
5
Ratio of AUCinf of plasma Saruparib relative to AUCinf of metabolite
Timeframe: Day 4
6
Mass balance parameters as characterized by amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined)
Timeframe: Day 8
7
Amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the administered dose