VRS-859 Single Ascending Dose Study in Diabetic Patients

• Research type

  Research Study

• Full title

  A Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-859 in Patients with Type 2 Diabetes Mellitus

• IRAS ID

  53574

• Sponsor organisation

  Versatis Inc

• Eudract number

  2010-019182-29

• ISRCTN Number

  finished

• Research summary

  VRS-859 is a glucagon-like peptide-1 (GLP-1) analog developed by Versartis Inc (a US company) to provide a beneficial, safe drug to help T2D patientscontrol their blood sugar. VRS-859 utilizes XTEN technology, natural hydrophilic amino acids with no pharmacological properties, to extend the half-life of exenatide (active ingredient) and maintain therapeutic Effectiveness up to 1 month. VRS-859 is a monthly injection, reducing the number of injections needed to control blood glucose levels and reducing gastrointestinal side effects. The Phase 1 objective is to assess the safety and tolerability of a single dose of VRS-859 in patientscurrently receiving oral medications for Type 2 diabetes. The Phase 1, double blind, placebo controlled, single ascending dose study with VRS859 is a first in man study. 55 male and female T2D patients will be studied in five treatment groups (of 11 patients consisting of 8 patients randomised to active drug and 3 patients to placebo. The planned starting dose is a12.5mg injection under the skin. Maximum dose is a150mg, injected under the skin. patients will participate in one treatment group, and riside in the CRU from Day -1, and be dosed on Day 1 after fasting. patients will be housed at the unit for minimum of 48 hours post dose for observation. Should any patient exhibit expected or unexpected safety concerns at the time of release they may remain the in the CRU for up to five days until the safety issue risolves or intervention is necessary. All dosed patients would return to the Unit for blood sampling and tests on Days 4, 8, 11, 15, 18, 22, 25, and 30 (end of study) from Day 1 dosing. patients will be givenoself assessment diary careas to record any safety issues. patients will attend a final follow up visit approximately Day 60.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/31

• Date of REC Opinion

  7 Jun 2010

• REC opinion

  Further Information Favourable Opinion