Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT06713369
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2024-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AZD5305 hADME in Patients With Advanced Solid Malignancies
Sponsor:
AstraZeneca
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AZD5305
Brief 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).
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).
Detailed Description:
This is an open-label, 2-part study in participants with advanced solid malignancies and will be conducted at multiple study sites.
Participants will be assessed for study eligibility prior to admission to the study site during a 28-day screening period. Participants will take part in both Parts A and B of the study.
Part A will assess the absolute bioavailability and evaluate the PK parameters of oral Saruparib and a radiolabelled IV microdose of \[14C\]-Saruparib
Participants will be admitted to the study site pre-dose of Part A and will remain resident at the study site for PK sampling and safety assessments.
A washout period will be observed between doses of Saruparib in Parts A and B.
Part B will assess the ADME of oral \[14C\]-Saruparib. Participants will be readmitted to the study site for Part B and will remain resident at the study site for excreta (urine, faeces, and any vomitus) collections, PK sampling, and safety assessments. Participants may be discharged from the study site prior to the last indicated day if both the following discharge criteria are met:
1. ≥ 90% mass balance recovery, and
2. \< 1% of the total radioactive dose is recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods.
Participants will return to the study site for a Follow-up Visit after the last dose of Saruparib which will include routine safety assessments. After the completion of Parts A and B, and following the Follow-up Visit, participants may be allowed further access to Saruparib.
Additional safety data collection will be conducted.
Participants will be assessed for study eligibility prior to admission to the study site during a 28-day screening period. Participants will take part in both Parts A and B of the study.
Part A will assess the absolute bioavailability and evaluate the PK parameters of oral Saruparib and a radiolabelled IV microdose of \[14C\]-Saruparib
Participants will be admitted to the study site pre-dose of Part A and will remain resident at the study site for PK sampling and safety assessments.
A washout period will be observed between doses of Saruparib in Parts A and B.
Part B will assess the ADME of oral \[14C\]-Saruparib. Participants will be readmitted to the study site for Part B and will remain resident at the study site for excreta (urine, faeces, and any vomitus) collections, PK sampling, and safety assessments. Participants may be discharged from the study site prior to the last indicated day if both the following discharge criteria are met:
1. ≥ 90% mass balance recovery, and
2. \< 1% of the total radioactive dose is recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods.
Participants will return to the study site for a Follow-up Visit after the last dose of Saruparib which will include routine safety assessments. After the completion of Parts A and B, and following the Follow-up Visit, participants may be allowed further access to Saruparib.
Additional safety data collection will be conducted.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: