Relative bioavailability of oral aprepitant compared to EMEND (117865)
Research type
Research Study
Full title
A Single Part, Three Period, Randomised, Open Label Study Designed to Compare the Relative Bioavailability of Oral Aprepitant Co-Crystal Formulations to EMEND (Reference) in the Fasted State in Healthy Subjects
IRAS ID
217471
Contact name
Dan Gooding
Contact email
Sponsor organisation
Nuformix Technologies Ltd
Eudract number
2018-004100-19
Duration of Study in the UK
0 years, 1 months, 24 days
Research summary
The Sponsor is developing the study drug, Aprepitant Co-Crystal Formulation, as a treatment to prevent nausea and vomiting caused by chemotherapy.
The study will look at how trial formulations (recipes) of the study drug are absorbed by the body and compare these results against absorption of the reference formulation, EMEND®. EMEND® is a drug that is currently used by patients to treat sickness and nausea.
The study will also look at the safety and tolerability of the different formulations of the study drug.
The study will consist of 3 study periods involving up to 12 healthy male volunteers. In each period, volunteers will receive one of three regimens (Regimen A-C). For Regimen A, subjects will receive 125 mg of aprepitant co-crystal formulation 1 as a capsule in the fasted state. For Regimen B, subjects will receive 125 mg EMEND® capsule in the fasted state. For Regimen C, subjects will receive 125 mg of aprepitant co-crystal formulation as a powder for oral suspension (a mixture of formulation in a liquid to drink) in the fasted state.
There will be a minimum washout of 7 days between each regimen. In each regimen, subjects will arrive on Day-1 and remain in the clinical unit for 48 hours post-dose until discharge.
A follow-up call will take place 5 to 7 days after final dose to ensure the ongoing wellbeing of the subjects.REC name
Wales REC 2
REC reference
19/WA/0014
Date of REC Opinion
17 Jan 2019
REC opinion
Favourable Opinion