LY2189265 - Atorvastatin DDI study

• Research type

  Research Study

• Full title

  Effect of LY2189265 on the Pharmacokinetics of Atorvastatin in Healthy Subjects

• IRAS ID

  65728

• Contact name

  Ashley Brook

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2010-021657-39

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Eli Lilly and Company is currently developing LY2189265 to improve blood sugar control in adults with type 2 diabetes mellitus. It is a long-acting analogue of glucagon-like-peptide 1. Preclinical and clinical experience to date support the use of LY2189265 as a once-weekly injection to improve blood sugar control in patients with type 2 diabetes mellitus, when used alone or in combination with other anti-diabetic agents. This is a single centre open label study in healthy male and female subjects. The study will take place in 2 periods and has a fixed sequence.Period 1: Each subject will receive a single dose of 40mg Atorvastatin on Day 1.Period 2: Each subject will receive a single dose of 1.5mg LY2189265 on Day 1 and a single dose of Atorvastatin on Day 3. There will be a washout period of 7 to 10 days between Day 1 in Periods 1 and Day 1 of Period 2. Atorvastatin will be administered orally as a tablet in the morning in the fasted state. LY2189265 will be administered as a single subcutaneous dose in the morning, irrespective of breakfast time.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/29

• Date of REC Opinion

  3 Nov 2010

• REC opinion

  Further Information Favourable Opinion