Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative … (NCT06899061) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
Bulgaria, Moldova, Romania41 participantsStarted 2025-03-25
Plain-language summary
A Phase I modular study to assess the effect of oral saruparib on other treatments in patients with advanced solid malignancies.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participants with documented evidence of locally advanced unresectable or metastatic solid tumours, excluding lymphoma, who have exhausted standard of care options (or for which no standard therapies exist) and may be suitable for saruparib monotherapy treatment in the opinion of the investigator.
✓. Adequate organ and marrow function (in the absence of transfusions or growth factor support within 28 days prior to enrolment).
✓. An ECOG PS: 0 to 1 with no deterioration within 1 week prior to the screening visit.
✓. Life expectancy ≥ 12 weeks.
Exclusion criteria
✕. Evidence of active and uncontrolled hepatitis B and/or hepatitis C. Screening for hepatitis B and hepatitis C is not required, criteria is based on medical history.
✕. Participants with controlled HIV need to meet the following criteria (screening for HIV is not required, criteria are based on medical history):
✕. Undetectable viral RNA load less than 400 copies/mL in the last 4 weeks prior to first dose of study intervention.
✕. CD4+ count of ≥ 350 cells/μL.
✕. No history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, and stable on the same anti-HIV medications for at least 6 months. Screening for HIV is not required.
✕. Any other evidence of diseases, such as severe or uncontrolled systemic diseases or active uncontrolled infections, including but not limited to uncontrolled major seizure disorder, active bleeding diseases, superior vena cava syndrome, or history of allogenic organ transplant
✕. Active tuberculosis infection
✕. Any of the following cardiac criteria:
What they're measuring
1
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
Timeframe: Period 1: Days 1 to 5. Period 2: Days 5 to 9
2
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
Timeframe: Period 1: Days 1 to 5. Period 2: Days 5 to 9
3
Module 1: Maximum observed plasma (peak) drug concentration (Cmax) of digoxin, furosemide, metformin and rosuvastatin when dosed alone and in combination with saruparib
Timeframe: Period 1: Days 1 to 5. Period 2: Days 5 to 9
4
Module 2: AUClast between DC and RC tablets of saruparib
Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3
5
Module 2: AUCinf between DC and RC tablets of saruparib
Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3
6
Module 2: Cmax between DC and RC tablets of saruparib
Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3
7
Module 2: AUClast of DC saruparib tablets in the presence and absence of rabeprazole relative to the RC tablet