A Drug Interaction Study of Simvastatin and Albiglutide

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01147692

Run by

GlaxoSmithKline

People needed

40

Starts

2010-05-19

Expected to finish

2010-08-27

Last updated by the study team

2017-06-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• GSK Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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