* Absolute Bioavailability Study of Milvexian (CV010-062/QSC205295)
Research type
Research Study
Full title
A Study to Assess the Absolute Oral Bioavailability of Milvexian Using a 14C-Microtracer and Oral Solution in Healthy Participants with Additional Food Effect Comparison of a Spray-Dried Dispersion Formulation of Milvexian in Capsules
IRAS ID
297264
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2021-000892-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 21 days
Research summary
The Sponsor is developing the test medicine, milvexian, to help stop thromboembolic events. Thromboembolic events are caused by the formation of a blood clot deep inside a blood vessel resulting in the blockage of blood flow through important organs like the heart and brain which can result in heart attacks and strokes.
The study involves radiolabelling (labelling the test medicine with radioactive 14C) which is used to locate the test medicine within the body. The study will try to identify the amount of the test medicine entering the body (absolute bioavailability) when taken as an oral solution or capsule, at different doses and in the fed and fasted state. The study will also look at how the test medicine is taken up by the body (pharmacokinetics) when given in the fed and fasted state. Safety and how well the test medicine is tolerated will be assessed.
The study will consist of 5 study periods involving up to 16 healthy male and female volunteers of non-childbearing potential. In period 1, volunteers will receive a single dose of the test medicine as an oral solution, followed 1 hour later by a radiolabelled dose of the test medicine given intravenously (directly into a vein), infused over 15 minutes. In periods 2 - 5, volunteers will receive a single dose of the test medicine as a capsule(s) in each period in a randomised order, at 2 different dose levels (25 mg and 200 mg) and in the fed (after a high-fat breakfast) and fasted state. There will be a minimum 72-hour washout between each dose. Volunteers will stay in the clinic from the day before dosing in period 1 (Day -1) until 72 hours post-final dose in period 5.
In period 5, there will be a follow-up call between day 6 and day 8 to ensure the ongoing wellbeing of volunteers.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0273
Date of REC Opinion
14 May 2021
REC opinion
Favourable Opinion