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

PHASE1RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 25, 2025

Primary Completion Date

July 21, 2026

Study Completion Date

November 19, 2026

Conditions
Advanced Solid Malignancies
Interventions
DRUG

Saruparib

"Module 1:~Period 2: participants will receive saruparib orally once daily from Day 1 to Day 9. On Day 5 saruparib will be administered orally in combination with the cocktail of substrates.~Period 3: participants will receive saruparib orally once daily for up to 3 cycles of 28 days each.~Module 2:~Period 1 and Period 2: participants will receive a single oral dose of DC or RC saruparib.~Period 3: participants will receive an oral dose of rabeprazole twice daily from Day 1 to 3, and a single oral dose of rabeprazole prior to DC saruparib on Day 4.~Period 4: participants will receive an oral dose of RC saruparib daily for 3 cycles."

DRUG

Digoxin

"Period 1: participants will receive a single oral dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1.~Period 2: participants will receive a single oral dose of the cocktail of substrates in combination with saruparib on Day 5."

DRUG

Furosemide

"Period 1: participants will receive a single oral dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1.~Period 2: participants will receive a single oral dose of the cocktail of substrates in combination with saruparib on Day 5."

DRUG

Metformin Hydrochloride

"Period 1: participants will receive a single oral dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1.~Period 2: participants will receive a single oral dose of the cocktail of substrates in combination with saruparib on Day 5."

DRUG

Rosuvastatin

"Period 1: participants will receive a single oral dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1.~Period 2: participants will receive a single oral dose of the cocktail of substrates in combination with saruparib on Day 5."

DRUG

Rabeprazole

Period 3: Participants will receive two doses of rabeprazole per day from Day 1 to 3. On Day 4, participants will receive a dose of rabeprazole followed by DC saruparib.

Trial Locations (4)

1618

RECRUITING

Research Site, Sofia

400015

RECRUITING

Research Site, Cluj-Napoca

MD-2025

RECRUITING

Research Site, Chisinau

022338

RECRUITING

Research Site, Bucharest

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY