A Drug Interaction Study With Albiglutide and Warfarin

An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects

This open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.

This Phase I open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.

Inclusion Criteria:

• male healthy volunteers in good health
• no clinically significant diseases or clinically significant abnormal laboratory values
• body mass index (BMI) is >/=18 kg and ≤30 kg/m2
• nonsmoker

Exclusion Criteria:

• positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
• any clinically relevant abnormality
• history of any anaphylactic reaction to any drug
• history of significant cardiovascular or pulmonary dysfunction
• history of excessive bleeding
• current or chronic history of liver disease
• history of alcohol or substance abuse
• history of thyroid disease or dysfunction
• history of gastrointestinal surgery or disease
• history of pancreatitis
• previously received any GLP-1 mimetic compound (e.g., exenatide)