Effect of Formulation and Food on PK of GDC-0810 in Females (117523)
Research type
Research Study
Full title
A phase 1, randomized, open-label, single center study to investigate the effect of formulation and food on the pharmacokinetics of GDC-0810 in females healthy subjects of non-childbearing potential
IRAS ID
193919
Contact name
Mindy Sivasubramanian
Contact email
Sponsor organisation
Genetech Inc.
Eudract number
2015-003730-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 16 days
Research summary
The Sponsor is developing the study drug, GDC-0810, for the potential treatment of breast cancer. Breast cancer is the most common cancer and the leading cause of cancer death in women worldwide. Tumour growth and progression in approximately 80% of all breast cancers depends on the oestrogen receptor, a protein that is activated by the presence of the oestrogen hormone.
The study drug, GDC-0810, is a potent blocker of the oestrogen receptor. This causes the blockade of oestrogen resulting in the prevention of breast cancer cell tumour growth and progression. The study will investigate the effect of formulation and food on how well the body takes up the study drug.
The study will consist of 3 parts involving up to 48 healthy female subjects. In every part subjects will be randomised to one of three treatment sequences where they will receive a single dose of GDC-0810 in each treatment period. Part 1 consists of four treatment periods and Parts 2 and 3 consist of three treatment periods.
Parts 1 and 2 will investigate how well the body takes up new formulations of the study drug when subjects are given a low-fat meal, compared to a reference formulation of the study drug. Part 2 is an optional part of the study in which subjects will only be enrolled following a decision meeting based upon various safety data. Part 3 will investigate the effect of food on how well the body takes up the study drug. The optimised formulation tablet from parts 1 and 2 (if subjects are enrolled in Part 2) will be selected and will be given in a fasted and fed (low-fat meal) state. This will be compared to the reference formulation tablet given after a low-fat meal.
REC name
Wales REC 1
REC reference
15/WA/0432
Date of REC Opinion
21 Dec 2015
REC opinion
Further Information Favourable Opinion