Oral Bioavailability of TAVT-45 Granules vs Zytiga Tablets (QSC205069)
Research type
Research Study
Full title
A Phase 1 Randomized Crossover Trial to Compare the Oral Bioavailability of TAVT-45 (abiraterone acetate) Granules for Oral Suspension and Zytiga® (abiraterone acetate) Tablets under Fed and Fasted Conditions in Healthy Male Volunteers
IRAS ID
297304
Contact name
Elizabeth Duus
Contact email
Sponsor organisation
Tavanta Therapeutics
Eudract number
2021-001232-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
The Sponsor is developing a new formulation (recipe) of abiraterone acetate for the potential treatment of certain types of prostate cancer. Abiraterone acetate is already available on prescription in the US and EU, marketed under the name Zytiga®, in tablet form. The new formulation is called TAVT-45, which is a granules for oral suspension formulation (granules reconstituted in liquid). The aim is to make it easier for patients to swallow the medicine, and to improve how the body processes the medicine and to decrease the effect food has on the blood levels of the test medicine.\n\nThe study will try to identify the relative bioavailability (the proportion of test medicine [TAVT-45 granules] that enters the body compared in two forms) of the test medicine compared to Zytiga®, in the fed and fasted state. Additionally, the study will assess the effect of food on the rate and extent of absorption of the test medicine. Safety and tolerability will also be assessed.\n\nThe study will consist of four study periods involving up to 16 healthy male volunteers. Volunteers will attend the clinical unit on four occasions, receiving a single dose of the test medicine in the fed and fasted state or reference Zytiga® in the fasted or modified fasted state, on each occasion. For each period, volunteers will enter the clinical unit on the day before dosing (Day -1) and will be dosed on the morning of Day 1. They will then remain in the unit until Day 4 (72 hours post-dose) when they will be discharged. There will be a minimum of seven days washout between dosing, to allow the previous dose of the test medicine to be removed from the body. Approximately one week after their final dose, volunteers will receive a follow-up phone call to ensure their continued wellbeing.\n
REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0309
Date of REC Opinion
29 Apr 2021
REC opinion
Further Information Favourable Opinion