AZD5305 hADME in Patients with Advanced Solid Malignancies - AZD5305

Study identifier:D9723C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

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

Medical condition

Locally advanced or metastatic solid tumor

Phase

Phase 1

Healthy volunteers

No

Study drug

Saruparib (AZD5305), [14C]-AZD5305 microtracer, [14C]-AZD5305 (therapeutic dose)

Sex

All

Estimated Enrollment

8

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 13 Nov 2024
Estimated Primary Completion Date: 06 May 2026
Estimated Study Completion Date: 06 May 2026

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Basic Science

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Fortrea

Inclusion and exclusion criteria