AZD5305 hADME in Patients With Advanced Solid Malignancies

Sponsor
AstraZeneca
Study ID
NCT06713369
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Locally Advanced or Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saruparib (AZD5305) — DRUG
    PARP-inhibitor
  • [14C]-AZD5305 microtracer — DRUG
    IV radiolabeled microtracer
  • [14C]-AZD5305 (therapeutic dose) — DRUG
    IV radiolabeled PARP inhibitor

Study Details

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).

Key Dates

Start date
Apr 2, 2025
Status verified
Mar 2026
Primary completion
Oct 2, 2026
Completion
Oct 2, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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

Primary Outcome Measure

Absolute bioavailability (F) of Saruparib [ Time Frame: Day 4 ]

Central Contacts