BIOAVAILABILITY AND PHARMACOKINETICS STUDY OF RO6811135

• Research type

  Research Study

• Full title

  AN OPEN LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO INVESTIGATE THE ABSOLUTE BIOAVAILABILITY AND PHARMACOKINETICS OF RO6811135 FOLLOWING SINGLE DOSE ADMINISTRATION BY SUBCUTANEOUS AND INTRAVENOUS ROUTE IN HEALTHY SUBJECTS.

• IRAS ID

  126431

• Contact name

  Jim Bush

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2012-005773-31

• ISRCTN Number

  N/A

• Research summary

  RO6811135 (study drug) is being developed as a potential treatment for type 2 diabetes mellitus. Type 2 diabetes (T2D) is a progressive metabolic disorder characterized by insulin resistance and pancreatic ß-cell failure. Insulin resistance is a condition in which a person's body tissues have a lowered level of response to insulin, a hormone secreted by the pancreas that helps to regulate the level of glucose (sugar) in the body therefore resulting in higher glucose levels and per-disposing to T2D. Pancreatic ß -cells are responsible form secreting insulin and thus failure of these cells would also contribute to reduced insulin secretion and higher glucose levels. T2D is recognized as a global epidemic with up to 285 million people affected by the disease word-wide. GLP-1 and GIP are naturally occurring peptide hormones secreted from intestinal cells in response to ingestion of food. Both GLP-1 and GIP play a major role in regulation of glucose levels by stimulating insulin secretion in a glucose-dependent manner (incretin effect) in addition to other effects which collectively result in better glucose control. Treatments with currently approved GLP-1 agonists result in improved glycemic control, either as a mono-therapy or in combination with other anti-hyperglycemic therapies. RO6811135 is a synthetic peptide analogue with homology (similarity) to both GLP-1 and GIP. It is hoped that this drug will control blood glucose levels in the body by mimicking the actions of the naturally secreted GLP-1 and GIP hormones. In this study, RO6811135 will be administered subcutaneously and intravenously to allow the quantification of RO6811135 absolute bioavailability (how much of the study drug gets into the blood stream when given as subcutaneous injection in comparison to intravenous infusion). This is a single site study involving up to 12 healthy male subjects. Subjects will be randomly assigned to receive a single subcutaneous dose of 0.4 mg RO6811135 or a single intravenous (IV) infusion of 0.4 mg RO6811135. The dose level may be lowered if there are intolerable adverse events or safety concerns, and may be increased if the study drug blood levels with the IV infusion are lower than expected. Subjects will receive both of these administrations in 2 separate treatment periods. Subject participation is expected to last up to 9 weeks from the time of screening till the last post-study visit.

• REC name

  North East - York Research Ethics Committee

• REC reference

  13/NE/0077

• Date of REC Opinion

  14 Mar 2013

• REC opinion

  Favourable Opinion