Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-28 @ 8:08 PM
Study NCT ID:
NCT06899061
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Modular Phase I, Open-label Study to Assess the Safety, Pharmacokinetics, and Drug Interaction Potential and Relative Bioavailability of Saruparib in Patients With Advanced Solid Malignancies
Status:
RECRUITING
Status Verified Date:
2025-12
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:
None
Brief Summary:
A Phase I modular study to assess the effect of oral saruparib on other treatments in patients with advanced solid malignancies.
Detailed Description:
Module 1 of the study is a Phase I, open-label study to assess the effects of saruparib on the PK of substrates digoxin (P-gp), furosemide (OAT1/3), metformin hydrochloride (OCT2/MATE1/2K), and rosuvastatin (OATP1B1/3) in participants with advanced solid malignancies.
Module 2 of the study is a Phase I, open-label, 4-treatment period, multi-centre, relative bioavailability, PPI effect, randomised, crossover study of saruparib tablets manufactured using a direct compression (DC) process in participants with advanced solid malignancies.
Module 1 of the study will include:
* A Screening period of 28 days prior to Day 1.
* Period 1: a single dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1.
* A washout period of 1 to 3 days between Period 1 and Period 2.
* Period 2: continuous dosing of saruparib from Day 1 to Day 9. On Day 5 saruparib will be administered in combination with the cocktail of substrates.
* Period 3: a dose of saruparib per day for up to 3 cycles of 28 days each.
* An End of Study visit up to 3 days after the last dose in Period 3.
Module 2 of the study will include:
* A Screening period of 28 days prior to Day 1.
* Period 1 and Period 2: a single dose of roller compaction (RC) or DC saruparib.
* Period 3: from Day 1 to 3, two doses of rabeprazole per day. On Day 4, a dose of rabeprazole followed by DC saruparib.
* A washout period of at least 3 days between Period 1 and Period 3, and between Period 2 and Period 3.
* Period 4: a single dose of RC saruparib for up to 3 cycles.
* An End of Study visit up to 3 days after the last dose in Period 4.
Module 2 of the study is a Phase I, open-label, 4-treatment period, multi-centre, relative bioavailability, PPI effect, randomised, crossover study of saruparib tablets manufactured using a direct compression (DC) process in participants with advanced solid malignancies.
Module 1 of the study will include:
* A Screening period of 28 days prior to Day 1.
* Period 1: a single dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1.
* A washout period of 1 to 3 days between Period 1 and Period 2.
* Period 2: continuous dosing of saruparib from Day 1 to Day 9. On Day 5 saruparib will be administered in combination with the cocktail of substrates.
* Period 3: a dose of saruparib per day for up to 3 cycles of 28 days each.
* An End of Study visit up to 3 days after the last dose in Period 3.
Module 2 of the study will include:
* A Screening period of 28 days prior to Day 1.
* Period 1 and Period 2: a single dose of roller compaction (RC) or DC saruparib.
* Period 3: from Day 1 to 3, two doses of rabeprazole per day. On Day 4, a dose of rabeprazole followed by DC saruparib.
* A washout period of at least 3 days between Period 1 and Period 3, and between Period 2 and Period 3.
* Period 4: a single dose of RC saruparib for up to 3 cycles.
* An End of Study visit up to 3 days after the last dose in Period 4.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-513692-41-00 | REGISTRY | EUCTR | View |