Status:
COMPLETED
A Drug Interaction Study With Albiglutide and Warfarin
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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 t...
Detailed Description
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 do...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01147731
Start Date
June 4 2010
End Date
September 9 2010
Last Update
June 22 2017
Active Locations (1)
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1
GSK Investigational Site
Austin, Texas, United States, 78744