Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT06899061
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.
Study:
NCT06899061
Study Brief:
Protocol Section:
NCT06899061