NCT04959266

A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, non-randomised, 3-arm (A, B, and C), drug-drug interaction study in patients with advanced solid tumours.

Detailed description

The study will include 3 arms consisting of a screening period of up to 28 days (Day -28 to Day -1), an intervention period (12 days for arm A, 17 days for arm B, and 12 days for arm C), and a follow-up end of treatment \[EOT\] visit (within 3 days after a 4-day washout period relative to the last dose of adavosertib). Arm A of this study follows a non-randomised, open-label, 2-intervention design. Patients will receive the following 2 study interventions: a single oral dose of adavosertib alone, and a single oral dose of adavosertib administered concomitantly with itraconazole. Arm B of this study follows a non-randomised, open-label, 2-intervention design. Patients will receive the following 2 study interventions: a single oral dose of adavosertib alone, and a single oral dose of adavosertib administered concomitantly with rifampicin. Arm C of this study follows a non-randomised, open-label, 2-intervention design. Patients will receive the following 2 study interventions: a single oral dose of adavosertib alone, and a single oral dose of adavosertib administered concomitantly with omeprazole.

Conditions

• Advanced Solid Tumours

Interventions

Type	Name	Description
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.
DRUG	Rifampicin	Patients will receive Rifampicin orally once daily for 13 days in arm B.
DRUG	Omeprazole	Patients will receive Omeprazole orally once daily for 5 days in arm C.

Timeline

• Start date: 2021-06-28
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-07-13
• Last updated: 2022-09-16

Locations

5 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study