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A Drug Interaction Study With Albiglutide and Warfarin

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01147731
First received: April 29, 2010
Last updated: January 22, 2011
Last verified: November 2010
History of Changes

April 29, 2010
January 22, 2011
June 2010
September 2010   (final data collection date for primary outcome measure)
The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide [ Time Frame: 52 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01147731 on ClinicalTrials.gov Archive Site
The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR). [ Time Frame: 52 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Drug Interaction Study With Albiglutide and Warfarin
An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects

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.

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.
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Diabetes Mellitus, Type 2
  • Healthy
Biological: warfarin plus albiglutide
A single dose of 25mg warfarin on day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 25mg warfarin on day 45.
Experimental: warfarin plus albiglutide
A single dose of 25mg warfarin on day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 25mg warfarin on day 45.
Intervention: Biological: warfarin plus albiglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2010
September 2010   (final data collection date for primary outcome measure)

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)
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01147731
111681
No
E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP