Study identifier:D601HC00006
ClinicalTrials.gov identifier:NCT04959266
EudraCT identifier:2020-005368-73
CTIS identifier:N/A
A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor), Rifampicin (a CYP3A4 Inducer), and Omeprazole (a Proton Pump Inhibitor) on the Pharmacokinetics of a Single Oral Dose of Adavosertib in Patients with Advanced Solid Tumours
Advanced Solid Tumours
Phase 1
No
Adavosertib, Itraconazole, Rifampicin, Omeprazole
All
5
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Other
Verified 01 May 2023 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm A Patients will receive a single oral dose of adavosertib alone, and a single oral dose of adavosertib concomitantly with itraconazole. | Drug: Adavosertib Patients will receive a single dose of Adavosertib orally in arm A, B, and C. Drug: Itraconazole Patients will receive Itraconazole orally once daily for 7 days in arm A. |
Experimental: Arm B Patients will receive a single oral dose of adavosertib alone, and a single oral dose of adavosertib concomitantly with rifampicin. | Drug: Adavosertib Patients will receive a single dose of Adavosertib orally in arm A, B, and C. Drug: Rifampicin Patients will receive Rifampicin orally once daily for 13 days in arm B. |
Experimental: Arm C Patients will receive a single oral dose of adavosertib alone, and a single oral dose of adavosertib concomitantly with omeprazole. | Drug: Adavosertib Patients will receive a single dose of Adavosertib orally in arm A, B, and C. Drug: Omeprazole Patients will receive Omeprazole orally once daily for 5 days in arm C. |