Phase 1 PK and safety study of DRGT-45 (DRGT45C03/QSC203230)
Research type
Research Study
Full title
A Phase 1 Randomized Crossover Trial to Evaluate the Pharmacokinetics and Safety of Single Doses of DRGT-45 (abiraterone acetate) Tablets for Oral Suspension (Part 1) and to Compare the Oral Bioavailability of DRGT-45 Tablets and Zytiga® (abiraterone acetate) Tablets under Fed and Fasted Conditions (Part 2) in Healthy Male Volunteers
IRAS ID
271525
Contact name
Litza McKenzie
Contact email
Sponsor organisation
Druggability Technologies Holdings Ltd
Eudract number
2019-003417-34
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
The Sponsor is developing a new formulation (recipe) of the test medicine, abiraterone acetate, for the potential treatment of prostate cancer. Abiraterone acetate is currently available on prescription as a drug called Zytiga® which is marketed 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. Zytiga® decreases the amount of testosterone made by the body which can slow the growth of prostate cancer.\n\nThe sponsor is developing a new formulation of abiraterone acetate called DRGT-45, with the aim to improve how the body processes the medicine and to decrease the effect food has on the blood levels of the test medicine. \n\nThis study will consist of 2 separate parts. Part 1 will assess how the body absorbs the test medicine when given in different amounts. Part 2 will assess the levels of medicine in the blood when the test medicine is given fasted compared to when given with food and will also compare this to Zytiga®. We will also look at the safety and tolerability of the test medicine. \n\nIn Part 1, 12 healthy male volunteers will receive single doses of DRGT-45 under fasted conditions on 4 occasions (periods). In Part 2, 20 healthy male volunteers will receive single doses of DRGT-45 or the reference Zytiga® tablets under fed and fasted conditions on 4 occasions (periods). \n\nIn both parts, there will be at least a 7-day washout period between dosing, and volunteers will remain in the clinical unit until discharge on Day 4 of each period. Volunteers will then have a follow up call approx. 1 week after their final dose to ensure their continued wellbeing.\n
REC name
Wales REC 2
REC reference
19/WA/0246
Date of REC Opinion
12 Sep 2019
REC opinion
Favourable Opinion