PK study of abiraterone immediate release formulations (QSC201056)
Research type
Research Study
Full title
A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations
IRAS ID
259861
Contact name
Tomas Martinu
Contact email
Sponsor organisation
Zentiva, k.s.
Eudract number
2019-000214-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
The Sponsor is developing a new formulation (recipe) of the test medicine, abiraterone acetate (Zytiga). Zytiga is a marketed medicine in the USA and EU for the treatment of prostate cancer. Prostate cancer is the most common cancer in men in the UK and usually develops slowly, so there may be no signs of the condition for many years. The Sponsor is developing different formulations of the test medicine with the aim to improve how the body processes the medicine and to decrease the effect food has on it.\n\nThe study will investigate the pharmacokinetic (PK - what the body does to the drug) profiles of different immediate release (IR) prototype formulations of abiraterone, and compare the relative bioavailability (level of test medicine present in the blood) of the IR prototype formulations to a Zytiga® IR reference tablet. Food effect on one of the prototype formulations will also be investigated.\n\nThe study will consist of 2 parts involving 36 healthy male volunteers. \nIn Part 1, 24 volunteers will attend the clinical unit on 3 occasions and receive one of 2 prototype formulations and the reference Zytiga tablets in a random order. After review of the data from the first 3 periods, they will receive 1 prototype formulation at a different dose level to achieve the same levels of drug in the body as 1000 mg Zytiga. \n\nIn Part 2, 12 volunteers will attend the clinical unit on 2 occasions to receive a selected prototype formulation under fed and fasted conditions. The formulation and dose to be given in Part 2 will be decided after completion of Part 1. \n\nFor both Parts, volunteers will be discharged 24 hours after each dose. There will be a minimum of 7 days between dosing. Volunteers will receive a follow-up phone call after their final dose.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0194
Date of REC Opinion
4 Jun 2019
REC opinion
Favourable Opinion