Status:
COMPLETED
A Drug Interaction Study of Simvastatin and Albiglutide
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 o...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01147692
Start Date
May 19 2010
End Date
August 27 2010
Last Update
June 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Austin, Texas, United States, 78744