Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib

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.