Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
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Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Other
Enrollment
41actual
Sites
4
Countries
Bulgaria, Moldova, Romania
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-25 | actual | When the study began enrolling |
| Primary completion | 2026-02-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-05-19 | estimated | The whole study's end, after follow-up |
| First posted | 2025-03-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Malignancies
Interventions
- Drug: Saruparib
- Drug: Digoxin — also filed as P-gp
- Drug: Furosemide — also filed as OCT2
- Drug: Metformin Hydrochloride — also filed as OAT1/3, MATE1/2K
- Drug: Rosuvastatin — also filed as OATP1B1/3
- Drug: Rabeprazole
Primary outcomes
what the primary-completion date above is the date OFModule 1: Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf) of digoxin, furosemide, metformin and rosuvastatin when dosed alone and in combination with saruparib
measured Period 1: Days 1 to 5. Period 2: Days 5 to 9
Module 1: Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of digoxin, furosemide, metformin and rosuvastatin when dosed alone and in combination with saruparib
measured Period 1: Days 1 to 5. Period 2: Days 5 to 9
Module 1: Maximum observed plasma (peak) drug concentration (Cmax) of digoxin, furosemide, metformin and rosuvastatin when dosed alone and in combination with saruparib
measured Period 1: Days 1 to 5. Period 2: Days 5 to 9
Module 2: AUClast between DC and RC tablets of saruparib
measured Period 1: Days 1 to 3. Period 2: Days 1 to 3
Module 2: AUCinf between DC and RC tablets of saruparib
measured Period 1: Days 1 to 3. Period 2: Days 1 to 3
Module 2: Cmax between DC and RC tablets of saruparib
measured Period 1: Days 1 to 3. Period 2: Days 1 to 3
Module 2: AUClast of DC saruparib tablets in the presence and absence of rabeprazole relative to the RC tablet
measured Period 3: Days 4 to 6
Module 2: AUCinf of DC saruparib tablets in the presence and absence of rabeprazole relative to the RC tablet
measured Period 3: Days 4 to 6
Module 2: Cmax of DC saruparib tablets in the presence and absence of rabeprazole relative to the RC tablet
measured Period 3: Days 4 to 6
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