Evaluating optimal dosing conditions of GLP-1analogue in healthy males
Research type
Research Study
Full title
Evaluation of optimal dosing conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects
IRAS ID
147809
Contact name
Annelize Koch
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2012-003855-13
ISRCTN Number
n/a
Research summary
The new medicine tested in this trial is a compound called NNC0113-0987. Novo Nordisk is developing the NNC0113-0987 for treating patients with type-2 diabetes.
NNC0113-0987, is not yet licensed, but has been given to humans before in clinical trials. The trial drug belongs to a class of drugs called GLP-1 receptor agonists (activators of the GLP-1 receptor). Two clinical trials have been conducted with the trial drug given intravenously (directly into the blood stream) and via the oral route (as a tablet) and no major safety issues were identified in these trials. It is hoped that the trial drug will be useful as a treatment for type-2 diabetes.
It is expected that intake of meals and fluid have an influence on the uptake of NNC0113-0987. Therefore, strict dosing conditions were in place for the previous trials with NNC0113-0987. The purpose of the present trial is to investigate whether a period of fasting after dosing is required in order to allow proper uptake of NNC0113-0987 from the gut to the blood stream. The effect of different amounts of water taken with the trial drug (given as a tablet) will also be investigated. The uptake of the trial drug will be measured in blood samples, where the pharmacokinetic properties (i.e., how much of the trial drug is in your body over a certain period of time) will be measured.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0201
Date of REC Opinion
25 Feb 2014
REC opinion
Favourable Opinion