A Drug Interaction Study of Simvastatin and Albiglutide

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

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

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

Inclusion Criteria:

• no clinically significant diseases or clinically significant abnormal laboratory values
• females must be of non-childbearing potential
• body mass index (BMI) is >/=18 kg and ≤30 kg/m2
• nonsmoker
• negative drug screen

Exclusion Criteria:

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