Bioavailability and food effect of a GDC-0276 tablet (QCL117781)
Research type
Research Study
Full title
A Single-Dose, Open-Label, Randomized,4-Way Crossover Study to Assess the Relative Bioavailability and Food Effect of a Tablet Formulation of GDC-0276 in Healthy Subjects
IRAS ID
206659
Contact name
Maria Regalado-Dell
Contact email
Sponsor organisation
Genentech Inc
Eudract number
2016-001572-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 25 days
Research summary
The Sponsor is developing the study drug, GDC-0276, for the potential treatment of long-term pain. \n\nThe study will try to identify how the body takes up the study drug when given as a tablet on an empty stomach, compared with a capsule form of the study drug. The effect of food on the tablet will also be studied, with subjects receiving the tablet after a high-fat and a low-fat meal. The safety and tolerability of the study drug will also be assessed. \n\nThe study will consist of 4 study periods involving up to 24 healthy male and female subjects. In Period 1, subjects will receive a 270 mg dose of GDC-0276 given as three capsules on an empty stomach. In Period 2, subjects will receive a 270 mg dose of GDC-0276 given as three tablets on an empty stomach. In Period 3, subjects will receive a 270 mg dose of GDC-0276 given as three tablets following a high-fat meal, and in Period 4, subjects will receive a 270 mg dose given as three tablets of GDC-0276 tablets following a low-fat meal. \n
REC name
HSC REC B
REC reference
16/NI/0094
Date of REC Opinion
13 Jun 2016
REC opinion
Favourable Opinion