Study identifier:D9723C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Locally advanced or metastatic solid tumor
Phase 1
No
Saruparib (AZD5305), [14C]-AZD5305 microtracer, [14C]-AZD5305 (therapeutic dose)
All
8
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Basic Science
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
Fortrea
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Primary Treatment Arm - AZD5305 Part A will assess absolute bioavailability via oral administration of Saruparib (AZD5305) and IV [14C]-saruparib microtracer. Part B will assess ADME via IV [14C]-saruparib administration | - |