Effect of Food, Rabeprazole and Formulation on GDC-0853 PK(QCL117979)
Research type
Research Study
Full title
A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects
IRAS ID
224931
Contact name
Nand Singh
Contact email
Sponsor organisation
Genentech Inc
Eudract number
2017-000752-26
Duration of Study in the UK
0 years, 10 months, 10 days
Research summary
The Sponsor is developing the study drug, GDC-0853, for the potential treatment of autoimmune diseases such as Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE) and Chronic Spontaneous Urticaria (CSU). An autoimmune disease develops when your immune system, which aims to defend your body against disease, identifies its own body’s cells as foreign invaders causing it to attack your own body tissues.\nThe test medicine will be dosed in up to 5 different tablet formulations (recipes) to find which recipe delivers the most test medicine into the blood circulation. The effect of dosing in combination with rabeprazole, a protein pump inhibitor (PPI), and food will also be investigated. \nPPIs are a group of drugs which reduce acid production in the stomach and are used to treat and prevent acid-related conditions such as ulcers and heartburn. It is believed that acid reducing agents such as rabeprazole could have an impact on how the test medicine is taken up by the body.\nIn Part 1, up to 15 subjects will receive a single dose of 200 mg of the test medicine on 5 separate occasions. Each dose will be given in the fasted state and in combination with 20 mg rabeprazole.\nIn Part 2, up to 24 subjects will receive a single dose of 200 mg test medicine on 3 separate occasions. A formulation chosen from Part 1 will be given in the fasted state, in the fed state and in combination with 20 mg rabeprazole (either fed or fasted).\nIn optional Part 3, up to 24 subjects may receive a single dose of test medicine on 3 separate occasions. An optimised formulation and dose based on data from Part 1 and Part 2 and will be given in the fasted state, in the fed state and in combination with 20 mg rabeprazole (either fed or fasted).\n
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/1146
Date of REC Opinion
26 Jul 2017
REC opinion
Further Information Favourable Opinion