D6014C00005, Phase I, Open-label, Food Effects of AZD1775
Research type
Research Study
Full 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
IRAS ID
228687
Contact name
Jeff Evans
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-001909-17
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
The purpose of this study is to assess the effect of food on the pharmacokinetics (PK - how the body absorbs, breaks down and removes) of a single dose of AZD1775 depending on whether it's taken on a full or empty stomach. Each participant will be randomised to 1 of 2 treatment groups; Fasted (Treatment A) or Fed (Treatment B). Both treatment groups will receive the same dose orally (300 mg, as 3 x 100 mg capsules). Participants will take part in 2 randomised treatment sequences (Period 1 and Period 2) each separated by a washout period of at least 5 but no more than 14 days.
The study consists of a Screening Period (lasting up to 28 days), a Treatment Period (consisting of 2 sequences, each lasting 4 days with a washout period between) and an End of Treatment (EoT) visit (between 4 to 7 days after leaving the study centre in Period 2). Upon completing this study, participants will be offered to enrol in the open-label Continue Access (CA) study to further assess the safety and tolerability of AZD1775. All participants are required to have an EoT visit. If the participant is interested in the CA study, they may be consented for CA study at this time for evaluation of eligibility. If participant meets entry criteria for CA study, then EoT assessment can also be used as screening visit for CA study.
The End of Study (EoS) visit is only required for participants who are not interested in, or not eligible for the CA study. To take place within 30 days from last dose of AZD1775.
Approximately 7 study centres in Western Europe will participate. A total of 24 participants, with advanced solid tumours, will be enrolled to ensure that at least 18 evaluable participants complete the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0255
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion