bsolute Oral Bioavailability Study of Saxagliptin in Healthy Subjects
Research type
Research Study
Full title
Study of the Absolute Oral Bioavailability of Saxagliptin in Healthy Subjects Quotient Clinical Study No: QCL-106186
IRAS ID
55573
Contact name
Stuart J Mair
Sponsor organisation
Bristol-Myers Squibb Research and Development
Eudract number
2010-020903-60
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The drug that is under investigation in this study is saxagliptin. Saxagliptin is an oral anti-diabetic drug which has been approved and licensed in the United States and the European Union for the treatment of type 2 diabetes mellitus in adult patients. The purpose of this study to investigate the levels of study drug (saxagliptin) in the blood after taking an oral dose of the drug as a tablet and comparing this with a radiolabelled dose of the same study drug administered intravenously (the drug will be injected into a vein in the arm). This information will then be used to calculate the exact percentage of the oral dose that enters the blood stream. The safety and tolerability of the drug will also be assessed. Eight healthy male volunteers aged between 18 - 55 years who meet the inclusion/exclusion criteria will participate in the study. The study consists of a screening visit and one dosing/in-patient observation period, during which the subjects will be resident for 2 nights (from admission on Day -1 until discharge on Day 2).Each subject will receive a single oral dose of saxagliptin administered as a tablet, followed by a single dose of 14C-saxagliptin administered intravenously (into a vein in the arm) one hour later. The intravenous dose will contain a very small amount of radioactivity (carbon 14 or 14C) which will be used to track the drug in the body. The study will be conducted at one site - Quotient Clinical, Edinburgh.
REC name
Scotland A REC
REC reference
10/IEC02/20
Date of REC Opinion
19 Jul 2010
REC opinion
Further Information Favourable Opinion