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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Module 2: AUClast between DC and RC tablets of saruparib

Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3

Module 2: AUCinf between DC and RC tablets of saruparib

Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3

Module 2: Cmax between DC and RC tablets of saruparib

Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3

Trial details

NCT IDNCT06899061

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-03

View on ClinicalTrials.gov More Advanced Solid Malignancies trials

Who can participate

Age range

18 Years

Sex

ALL

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.

What they're measuring

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

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

Module 2: AUClast between DC and RC tablets of saruparib

Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3

Module 2: AUCinf between DC and RC tablets of saruparib

Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3

Module 2: Cmax between DC and RC tablets of saruparib

Timeframe: Period 1: Days 1 to 3. Period 2: Days 1 to 3