A Phase 1 Study to Investigate PK of GDC-0853 (QCL117578)
Research type
Research Study
Full title
A Phase 1, Single Center, Randomized, Open-Label Study Investigating the Effect of Food, Rabeprazole and Formulation on the Pharmacokinetics of GDC-0853 in Healthy Subjects
IRAS ID
182970
Contact name
Mindy Sivasubramanian
Sponsor organisation
Genentech, Inc.
Eudract number
2015-002471-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 25 days
Research summary
The Sponsor is developing the study drug, GDC-0853, for the potential treatment of rheumatoid arthritis (RA).
The study will look at two different formulations of the study drug, a tablet and a powder in capsule formulation, and will try to identify how food and proton pump inhibitors (PPIs) affect the way the study drug is taken up by the body.
The study will consist of 2 parts involving up to 32 healthy male and female subjects. Both parts will consist of 3 periods, and will follow a crossover design. In Part 1, up to 16 subjects will receive a dose of 200mg study drug (tablet or capsule formulation) in periods 1 and 2; in period 3, subjects will receive the tablet formulation after receiving a PPI (rabeprazole) for 3 days. All treatments in Part 1 will be given without food.
In Part 2, subjects will receive the tablet formulation of the study drug. Up to 16 subjects in periods 1 and 2 will receive the study drug with or without food; in period 3, subjects will receive the study drug after food, after receiving the PPI for 3 days.
In both parts, blood samples will be taken at specified timepoints to determine the levels of study drug present in the blood. The safety and tolerability of the study drug will also be assessed.
REC name
Wales REC 1
REC reference
15/WA/0216
Date of REC Opinion
4 Aug 2015
REC opinion
Further Information Favourable Opinion