Phase I study to assess the effect of food on AZD1775 pharmacokinetics in patients with Advanced Solid Tumours

Study identifier:D6014C00005

ClinicalTrials.gov identifier:NCT03315091

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of AZD1775 After Oral Dosing of a Capsule Formulation in Patients with Advanced Solid Tumours

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

No

Study drug

Treatment A - AZD1775 administered under fasted conditions, Treatment B - AZD1775 administered under fed conditions.

Sex

All

Actual Enrollment

31

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 29 Sept 2017
Primary Completion Date: 05 Apr 2018
Study Completion Date: 05 Apr 2018

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Quintiles, Inc.

Inclusion and exclusion criteria