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RECRUITING
NCT06713369
PHASE1

AZD5305 hADME in Patients With Advanced Solid Malignancies

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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).

Official title: A Phase I, Open-label Study to Assess the Absolute Bioavailability of Saruparib (AZD5305) and Absorption, Distribution, Metabolism, and Excretion (ADME) of [14C]-Saruparib ([14C]-AZD5305) in Patients With Advanced Solid Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2025-04-02

Completion Date

2026-10-02

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Saruparib (AZD5305)

PARP-inhibitor

DRUG

[14C]-AZD5305 microtracer

IV radiolabeled microtracer

DRUG

[14C]-AZD5305 (therapeutic dose)

IV radiolabeled PARP inhibitor

Locations (2)

Research Site

Liverpool, United Kingdom

Research Site

Manchester, United Kingdom