Bioavailability and food effect study of Belvarafenib (GDC-5573)
Research type
Research Study
Full title
A Phase I, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Belvarafenib (GDC-5573) in Healthy Subjects.
IRAS ID
262577
Contact name
Lisa Husband
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2019-001571-36
Clinicaltrials.gov Identifier
262577, IRAS Number
Duration of Study in the UK
0 years, 3 months, 18 days
Research summary
Belvarafinib (GDC-5573), the study drug, is being developed as a novel anti-cancer treatment for certain skin, bowel, lung, liver and pancreatic cancers. The drug works by inhibiting a molecule involved in the multiplication and survival of cancer cells. The study drug has been given to cancer patients but this is the first study in healthy volunteers. \n\nThe aim of the study is to determine how the Phase 1 form (the form used in previous clinical studies) of study drug compared to the Phase 2 form (the form that is planned to be used in the future) at a dose of 200mg, if the amount of study drug that gets into the bloodstream from the different forms is similar, if food affects the amount of study drug getting into the bloodstream, its safety and any side effects that might be associated with it.\n\nA maximum of 18 volunteers will participate in the study. Subjects will be randomly assigned to 1 of 6 different sequences receiving 3 treatments A, B and C: \n \nA: 200mg Phase 1 GDC-5573 orally in a fed state \nB: 200mg Phase 2 GDC-5573 orally in a fed state\nC: 200mg Phase 2 GDC-5573 orally in a fasted state \n\nSubjects will participate in three treatment periods, separated by an 18-day washout, and will remain in the CRU (Clinical Research Unit) for a 24-hour observation period. They will attend outpatient visits on Days 3, 4, 5, 6, 8 and 10. In the first group, two subjects on Treatment C will be dosed 24 hours before the remainder of the subjects, to assess safety as the amount of drug absorbed is possibly higher without food. All subjects will attend a follow up visit 28 days after the final dose. \n
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0154
Date of REC Opinion
24 May 2019
REC opinion
Favourable Opinion