4-treatment crossover relative bioavailability in healthy subjects

• Research type

  Research Study

• Full title

  An open-label, randomized, 4-treatment crossover study to determine, in healthy subjects the relative bioavailability of single subcutaneous injection of lixisenatide administered at different concentrations and the absolute bioavailability

• IRAS ID

  99088

• Contact name

  Ashley Brooks

• Sponsor organisation

  Sanofi-Aventis Recherche & Development

• Eudract number

  2011-006045-15

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Glucagon-like peptide-1 (GLP-1) is hormone secreted by intestinal cells, which reduce glucose levels in blood. Lixisenatide (AVE0010) belongs to the class of GLP-1 receptor agonists (increase insulin levels in blood in response to food) and is being developed for the treatment of patients with type 2 diabetes mellitus (T2DM). Each subject enrolled into the study will receive Lixisenatide 4 times during the course of the study. The aim of the study is to assess how much of the drug is available to the body when the same amount of the drug is injected in different concentrations. During the study 15 healthy males and females will be randomized to receive 20 æg of Lixisenatide given as an injection under the skin in first 3 treatment periods. In each treatment period the study drug will be given in a formulation which differs in the concentration of lixisenatide present in it. All the subjects will receive 5æg of the study drug as an injection in a vein in the fourth treatment period. The subjects will be residential in the unit from 1 day prior to the first dose and will be discharged on the second day after the last dose. There will be at least 48 hr intervals between successive doses. There will be an end of study visit 5-8 days after the last dose. The total duration of the study including the screening period would be approximately 47 days. The subjects given the study drug will be assessed for development of antibodies to the study drug. If the subjects are found to have developed antibodies to the study drug when checked at the last visit, they may be asked to attend another visit to the unit after approximately 3-6 months after the last dose to reassess the presence of antibodies.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0093

• Date of REC Opinion

  21 Feb 2012

• REC opinion

  Favourable Opinion