A Drug Interaction Study With Albiglutide and Warfarin
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2; Healthy
Intervention: warfarin plus albiglutide (Biological)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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 the pharmacokinetics of warfarin.
Clinical Details
Official title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide
Secondary outcome: The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).
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 doses on the pharmacokinetics of warfarin.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
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)
Locations and Contacts
GSK Investigational Site, Austin, Texas 78744, United States
Additional Information
Starting date: June 2010
Last updated: January 22, 2011
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