Effects of AZD1775 on the PK substrates for CYP3A, CYP2C19, CYP1A2 and on QT interval in patients with advanced cancer

Study identifier:D6014C00006

ClinicalTrials.gov identifier:NCT03333824

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of AZD1775 on the Pharmacokinetics of Substrates for CYP3A, CYP2C19, CYP1A2 and to Provide Data on the Effect of AZD1775 on QT Interval in Patients with Advanced Solid Tumours

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

No

Study drug

CYP1A2 (caffeine), CYP2C19 (omeprazole), CYP3A (midazolam), Kytril (granisetron), Wee-1 kinase inhibitor AZD1775

Sex

All

Actual Enrollment

33

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Dec 2017
Primary Completion Date: 22 Jan 2019
Study Completion Date: 22 Jan 2019

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Quintiles, Inc.

Inclusion and exclusion criteria