PK in Healthy Males dosed with Novel Oral Abiraterone Acetate(117603)
Research type
Research Study
Full title
A Phase 1 Study With A Novel Abiraterone Acetate Powder in Bottle (PiB) Formulation In Healthy Male Subjects To Evaluate The Pharmacokinetics Of The Novel Abiraterone Acetate PiB Formulation And The Effect of Food
IRAS ID
184579
Contact name
Katalin Ferenczi
Contact email
Sponsor organisation
Druggability Technologies Holdings Ltd
Eudract number
2015-002759-83
Duration of Study in the UK
0 years, 2 months, 10 days
Research summary
The Sponsor is developing a novel oral formulation of the study drug, Abiraterone Acetate, for the treatment of Prostate cancer. \n\nThe study will try to identify if changes in the formulation of the study drug will have a notable effect on the absorption of the study drug and quantity of active ingredient available in the body. It is hoped that this modification will lead to a reduction in food effect seen with the current marketed product.\n\nThe study will consist of up to 3 study regimens involving up to 12 healthy male subjects in all regimens. In regimen A, subjects will receive a dose of 100 mg study drug administered in the fasted state. Regimen B subjects will receive either 200mg or 50mg in the fasted state, or 100mg in the fed state depending on emerging data. Regimen C is an optional regimen and will consist of 200 mg or 50 mg administered in the fed state (dependent on previous dose level) or 100 mg administered in the fed state if not previously tested..
REC name
HSC REC A
REC reference
15/NI/0144
Date of REC Opinion
10 Aug 2015
REC opinion
Further Information Favourable Opinion