PK Profile Study of Aprepitant Lipidic Capsule (QSC206159)
Research type
Research Study
Full title
A Single-Part, Five-Period, Sequential, Open-Labelled Study Designed to Evaluate the Safety and Pharmacokinetic Profile of Varying Doses of Aprepitant Following Administration of a Lipidic Capsule Formulation (LipAprep) in Healthy Subjects
IRAS ID
1005687
Contact name
Simon Yaxley
Contact email
Sponsor organisation
Oxilio Limited
ISRCTN Number
ISRCTN51392723
Research summary
The Sponsor is developing a new recipe of the test medicine, aprepitant, for the potential treatment of cancer. Aprepitant is currently used to treat nausea and vomiting related to chemotheraphy, however in preclinical trials it was found to have anticancer effects at higher doses than currently given to patients. \n\nThis single part, healthy volunteer study will investigate the pharmacokinetics (PK, how a test medicine is taken up by the body), safety and tolerability of varying and increasing doses of a new recipe of the test medicine across up to 5 study periods. The currently marketed recipe of the test medicine may also be investigated at higher than licensed doses, and the effect of food may be explored.\n\nThis study will take place at one non-NHS site, enrolling up to 12 male volunteers aged between 18 and 55.\n\nIn each period, volunteers will receive single oral doses of the test medicine. In Period 1, volunteers will receive a 150 mg dose of the test medicine, and the results from Period 1 will determine the dose given in Period 2. Periods 3 – 5 are optional, and depending on results from the previous period, volunteers may receive a higher dose of the test medicine, or it may be given in the fed state. Volunteers may also receive a dose of the marketed product of aprepitant.\n\nVolunteers will be discharged on Day 3 in each period and will return to the clinical unit on Day 4 of each period for the collection of a PK blood sample and for any new adverse events (AE’s) to be recorded. There will be a break of at least 14 days between each period, to make sure there is no test medicine in the volunteers’ bodies before their next dose.\n\nVolunteers will receive a follow up phone call 5 to 7 days following the final dose.\n\nVolunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. \n\nVolunteers are expected to be involved in this study for 16 weeks from screening to the follow up call.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0549
Date of REC Opinion
21 Sep 2022
REC opinion
Further Information Favourable Opinion