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AZD5305 hADME in Patients With Advanced Solid Malignancies

NCT06713369 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-04

No results posted yet for this study

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).

Conditions

  • Locally Advanced or Metastatic Solid Tumor

Interventions

DRUG

Saruparib (AZD5305)

PARP-inhibitor

DRUG

[14C]-AZD5305 microtracer

IV radiolabeled microtracer

DRUG

[14C]-AZD5305 (therapeutic dose)

IV radiolabeled PARP inhibitor

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06713369 on ClinicalTrials.gov