Phase 1Active, not recruiting
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
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
- Sponsor
- AstraZeneca (Industry)
- Enrolment
- 41 enrolled
- Conditions
- Advanced Solid Malignancies
- Interventions
- Saruparib; Digoxin; Furosemide; Metformin Hydrochloride; Rosuvastatin; Rabeprazole
- Ages
- adults, older adults
- Registry
- NCT06899061
From the registry
A Phase I modular study to assess the effect of oral saruparib on other treatments in patients with advanced solid malignancies.
Primary outcomes
- Module 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
- 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
- Module 1: Maximum observed plasma (peak) drug concentration (Cmax) of digoxin, furosemide, metformin and rosuvastatin when dosed alone and in combination with saruparib
- Module 2: AUClast between DC and RC tablets of saruparib