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drugset / Trial / NCT06713369

AZD5305 hADME in Patients With Advanced Solid Malignancies

NCT06713369 ↗

Phase 1 Recruiting 8 enrolled AstraZeneca Fortrea · collab
Non-randomizedSingle-groupOpen-labelBasic science

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).

Timeline

Start
2025-04-02
Primary completion
2026-10-02
Completion
2026-10-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Saruparib Small molecule — Oral

Indications

No indication recorded.