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

Study identifier:D601HC00006

ClinicalTrials.gov identifier:NCT04959266

EudraCT identifier:2020-005368-73

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

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

Medical condition

Advanced Solid Tumours

Phase

Phase 1

Healthy volunteers

No

Study drug

Adavosertib, Itraconazole, Rifampicin, Omeprazole

Sex

All

Actual Enrollment

5

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Jun 2021
Primary Completion Date: 01 Jun 2022
Study Completion Date: 01 Jun 2022

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 May 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria