A Drug Interaction Study With Albiglutide and Warfarin
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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 doses on the pharmacokinetics of warfarin.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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