PK and Bioavailability Study of AZD4635 In Healthy Males (QSC118237)
Research type
Research Study
Full title
A Phase I, Open Label Study to Assess the Pharmacokinetics and Relative Bioavailability of AZD4635 in Non-Smoking Healthy Male Subjects, with the Option to Assess Food Effect, pH Effect and Absolute Bioavailability
IRAS ID
253462
Contact name
Suzanne Volpe
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-003366-14
Duration of Study in the UK
0 years, 4 months, 27 days
Research summary
The Sponsor is developing the test medicine, AZD4635, for the potential treatment of cancer. Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The cancerous cells can invade and destroy surrounding healthy tissue, including organs.
The study aims to compare how the test medicine is taken up by the body when given as a capsule and suspension (a powder mixed with liquid to drink). This study will also assess the level of study drug present in the blood with new recipes of the test medicine, and has the option to assess the effect of food and decreasing the acidity of the stomach on the uptake of the test medicine. There is also the option to give a radiolabelled dose of the test medicine directly into the vein.
The study will consist of 2 parts involving 6 periods, up to 20 healthy male volunteers will be enrolled. In Part A, the volunteers will attend the clinical unit for Periods 1 and 2, where they will be randomised to receive one dose of the test medicine at each period. There will be a break to review the data after Period 2. In Part B, the same volunteers will attend for 4 study periods (Periods 3-6). The treatments that will be given in Periods 3-6 will be decided based on the emerging data from the study. At each study period, the volunteers will be dosed on Day 1 and be discharged on Day 4. The volunteers will attend a return visit on Days 5 and 6. There will be a break of at least 9 days (or 14 days if there is an interim decision) between each period. The volunteers will have a follow up call 7 to 10 days after their final dose.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/1700
Date of REC Opinion
31 Oct 2018
REC opinion
Further Information Favourable Opinion